Intermittent catheter

ABSTRACT

An intermittent catheter, preferably a female intermittent catheter, is provided in an assembly. The assembly may include a cap which may be attachable to the base of the assembly in use, and/or a seal which misaligns with sealing surfaces of a chamber wall and a moveable insert in use. It may have a two-step deployment, and/or a sheath that pulls out a storage chamber. Internal and external housing may define the storage chamber. The housing may have a filling aperture and/or the storage chamber may comprise an insert configured to move axially in response to rotation.

CROSS REFERENCE TO RELATED DISCLOSURE

The present application is a continuation of International ApplicationNo. PCT/GB2022/05014 filed on Apr. 22, 2022 and claims the benefit of GBApplication No. 2105822.7 filed Apr. 23, 2021, the contents of which areincorporated herein in entirety.

TECHNICAL FIELD OF THE INVENTION

The present invention relates to an intermittent catheter (e.g. aurinary catheter).

BACKGROUND TO THE INVENTION

A catheter is a medical device comprising a hollow catheter tubedesigned for insertion into canals, vessels, passageways or bodycavities to permit injection, drainage or withdrawal of fluids orsubstances therefrom, or to ensure said canals, vessels, passagewaysetc. remain open. Urinary catheters are designed for use for insertioninto a user's bladder via the urethra to drain the bladder.

To maximise comfort and minimise the risk of trauma and/or infection, anouter surface of the catheter tube is typically wetted using a wettingagent prior to insertion by the user. In further developments, thecatheter tube itself comprises, is integrated with or is coated with ahydrophilic component (e.g. a hydrophilic polymer) which serves toreduce friction further upon application of the wetting agent.

Some catheters may be supplied pre-wetted in a packaging, for instance,where the catheter is at least partially submerged within wetting agentwithin the packaging. Whilst this may ensure the catheter tube isadequately wetted prior to use, such arrangements suffer in thatcomponents of the catheter other than the catheter tube such as agripper element or funnel can also become wetted. This has a detrimentaleffect of the experience of the user where it may become difficult tohold and direct the catheter tube as required. This is particularlyproblematic where the user is performing self-catheterisation. Further,having the catheter submerged may effectively reduce the shelf-life ofthe catheter due to long-term exposure of components of the catheter tomoisture.

It is therefore seen advantageous to provide a catheter which ma bewetted at or immediately prior to the point of use.

In an attempt to address this, some catheters are provided in packagingwhich includes a rupturable container or sachet within the packagingwhich a user may burst to release the wetting agent. Typically, thisinvolves the user squeezing the packaging to cause the container/sachetto break. However, such arrangements experience similar problems tothose discussed above where the wetting agent is allowed to come intocontact with other components of the catheter. Such arrangements alsoresult in the possibility of the catheter tube not being fully wetted,or indeed wetted at all, prior to use. This can be harmful for the user.

It is therefore advantageous to provide a catheter which includes ameans of supplying a wetting agent solely to the catheter tube toimprove user experience.

In further prior art solutions, the catheter may be packaged within apackaging which includes a wetting device. In use, the catheter tube maybe moved through the wetting device as the catheter is removed from thepackaging and in doing so wetting the catheter tube. Examples of suchcatheters are shown in PCT application No. PU/IB2018/001539 in the nameof ConvaTec Limited.

However, due to packaging constraints the amount of wetting agent ableto be contained in such wetting devices is low, and there thereforeremains a possibility of the catheter tube not being fully wetted insuch solutions, especially where the catheter is near the end of itsshelf life and some of the solution may have evaporated.

For mechanisms which wet the catheter tube from the distal end, aninsufficient volume of wetting agent may result in the tip end not beingwetted at all which is undesirable since the tip end will be introducedinto the urethra first and is hence most likely to cause injury ifinadequately wetted before use.

Further a minimum length of catheter is required for regulatory approvaland it is desirable to ensure that the length is wetted with a minimumimpact on the packaging size.

It is an aim of an embodiment or embodiments of the invention toovercome or at least partially mitigate one or more problems with theprior art and/or to provide an improved intermittent catheter.

SUMMARY OF THE INVENTION

The present invention provides a catheter assembly according to theappended claims.

An aspect of the present disclosure provides a catheter assemblycomprising: an external housing comprising a main body and a cap. Themain body and cap may form a sterile cavity for housing a catheter. Thecatheter may be configured to be removed from the external housing inuse. The main body may be elongate with an open end and a closed end.The cap and the closed end of the main body may comprise correspondingmating surfaces such that the cap is mountable on the closed end of themain body.

An aspect of the invention provides a catheter assembly comprising: anexternal housing comprising a main body and a cap, wherein the main bodyand cap form a sterile cavity for housing a catheter which is configuredto be removed from the external housing in use; wherein the main body iselongate with an open end and a closed end; and, wherein the cap and theclosed end of the main body comprise corresponding mating surfaces suchthat the cap is mountable on the closed end of the main body.

Providing a cap which is mountable on the closed end of the main bodyprovides a convenient location to store the cap whilst the catheter isbeing used.

The cap may be configured to be mounted to the closed end of the caseduring use of the catheter. Thus, in use, the cap may be removed fromthe main body to expose the catheter for withdrawal from the externalhousing and placed on the closed end of the main body. The cap may beretained on the closed end of the main body whilst the catheter is beingused. Following use, the catheter may be placed back within the mainbody and the cap replaced so as to house the catheter for disposal.

The temporary mounting of the cap to the main body may be resilientenough to withstand an amount of handling which might reasonably beexpected whilst the catheter is removed and used. For example, theexternal housing may be temporarily placed on a surface whilst thecatheter is used.

The mating surfaces may be any which allow the cap to be retainablymounted on the closed end of the main body. The mating surfaces may beprovided by an internal surface of the cap and an external surface ofthe main body.

The internal surface of the cap may comprise one radial projections. Theone or more radial projections may be ribs, or may be pips, pins, fins,or the like. The ribs may be longitudinally extending. The radialprojections may provide at least part of the mating surface. The radialprojections may mate with the external surface of the main body when thecap is mounted on the main body. The radial projections may be arrangedto engage with a catheter within the external housing when the cap andthe body form the sterile cavity. The radial projections may be arrangedto rotate the catheter when the cap is being removed from the main body.

One or both of the mating surfaces may comprise an overmoulded element.The overmoulded element may comprise a layer, ring or insert arranged onthe internal surface of the cap. The overmoulded element may comprise alayer, ring or projection arranged on the external surface of the mainbody. The overmoulded element may be comprised of softer material thanthe corresponding mating surface (that is, an overmoulded elementarranged on the internal surface of the cap may be comprised of amaterial softer than the main body, or alternatively, an overmouldedelement arranged on the external surface of the main body may becomprised of a material softer than the cap).

The mating surfaces may engage via an interference fit. The interferencefit may be provided by a suitably large contacting area between themating surfaces to allow for a frictional engagement suitable forretaining the cap on the main body. The interference fit may be referredto as a resistance fit.

The profiles of an internal surface of the cap and the external surfacesof the main body may correspond to one another. The mating surfaces maycomprise corresponding tapered profiles. The tapered profiles may beuniformly tapered such that the angle of the taper is constant along itslength.

The external housing may be suitable for an intermittent catheter. Thecatheter may be a female intermittent catheter. The catheter may have alength of between 90 min to 200 mm. The catheter may have a length ofbetween 100 mm and 150 mm or for example between 130 mm and 155 mm, suchas about 135 mm. The catheter assembly may have a length correspondingto the length of the catheter. For example, the length of the catheterassembly, i.e. the closed length of the casing may be between 2 mm and20 mm, for example between 2 mm and 15 mm, such as between 2 mm and 10mm longer than the length of catheter The catheter assembly (whenclosed) may have a length of 10 and 25 cm; it may have a length ofbetween 11 and 16 cm, for example, between 140 mm and 1.65 mm, such as142 mm.

The external housing may be suitable for a catheter assembly. Theexternal housing may be manufactured, imported and sold independently ofthe catheter. The catheter assembly may comprise a catheter.

The main body and/or cap may be rigid. The rigidity of the main body andcap may be configured to be resiliently deformable to aid theinterference fit of the cap on the closed end of the main body.

The external housing may be comprised of plastic. The external housingmay be comprised of thermoplastic. The cap and main body may becomprised of different materials. The external housing (optionally thecap or main body) may be comprised of polycarbonate the external housing(optionally the cap or main body) may be comprised of polyethylene; theexternal housing (optionally the cap or main body) may be comprised ofnylon. Preferably the external housing (optionally the cap or main body)may be comprised of polypropylene.

In one aspect, the present disclosure may provide a method of using acatheter assembly comprising an external housing comprising a cap and amain body. The main body may have a first end to which the cap issealably attached prior to use and a second end. The method may comprisethe steps of: removing the cap from a first end of the main body toexpose the catheter for use, and mounting the cap on the second end ofthe main body. The method may further comprise inverting the cap priorto mounting it to the second end of the main body. The method mayfurther comprise removing the catheter from the main body following (orprior to) mounting the cap on the second end of the main body. Themethod may further comprise replacing the catheter within the main bodyfollowing the removal of the catheter from the main body. The method mayfurther comprise dismounting the cap from the second end of the mainbody and replacing the cap on the first end of the main body. The methodmay comprise the step of twisting the cap to unscrew it from the mainbody. The step of twisting the cap may rotate the catheter in theassembly. The catheter may be rotated by radial projections on the cap,which may engage with the catheter, e.g. with corresponding radialprojections of the catheter. The radial projections on the cap mayfurther engage with the second end of the main body when the cap ismounted on the second end of the main body.

An aspect of the present disclosure provides a catheter assembly havinga longitudinal axis. The catheter assembly may comprise: a catheter anda wetting agent storage chamber. The wetting agent storage chamber maycomprise a chamber wall and a movable insert. The movable insert may beconfigured to move axially along the longitudinal axis with respect tothe chamber wall between a first position and a second position.

The first position may correspond to a sealed configuration in which thestorage chamber is sealed by a seal element. The seal element may bebetween the chamber wall and the movable insert. The seal element may beconfigured to align with sealing surfaces of the chamber wall and themovable insert in the first position.

The second position may be a position in which the seal is configured tobe axially misaligned with at least one of the sealing surfaces.

An aspect of the present disclosure provides a catheter assembly havinga longitudinal axis, the catheter assembly comprising: a catheter; and,a wetting agent storage chamber, the wetting agent storage chambercomprising a chamber wall and a movable insert, wherein the movableinsert is configured to move axially along the longitudinal axis withrespect to the chamber wall between a first position and a secondposition, wherein in the first position the storage chamber is sealed bya seal element located between the chamber wall and the movable insert;and, wherein the seal element is configured to align with sealingsurfaces of the chamber wall and the movable insert in the firstposition; and, wherein in the second position the seal is configured tobe axially misaligned with at least one of the sealing surfaces.

Advantageously the provision of a seal to seal the reservoir reduces theamount of wetting agent that is lost to evaporation or leakage prior touse. This is beneficial as it increases the certainty that there will besufficient wetting agent at the end of the shelf life. It may also allowthe storage chamber to contain less wetting agent as a smaller margin isrequired, thus the reservoir and therefore the overall packaging may besmaller.

Providing a catheter assembly having a storage chamber which is sealedusing a seal element which is configurable to be aligned with a sealingsurface in a first position and misaligned with the sealing surface in asecond position provides a seal with improved functionality.

For example, in some embodiments the seal may be opened in the secondposition such that a flow path can be created for the wetting agent toflow to a further chamber, such as the wetting chamber or a primingchamber. Hence, the seal element can be configured to act as a valve foropening the storage chamber.

In some embodiments, the seal may remain intact in the second positionsuch that the storage chamber remains functionally sealed, but thecontact pressure exerted by the seal element is reduced. This may allowthe movable insert to be withdrawn from the storage chamber when in thesecond position more readily whilst providing a tighter seal fortransportation and storage purposes when in the first position.

The seal element may be an elastomeric material. For example, the sealmay be a rubber seal or some other suitable material. The seal elementmay comprise an O-ring. The seal element may extend between radiallyopposed sealing surfaces. The O-ring may lie in a radial plane, forexample, the normal plane of the longitudinal axis of the catheterassembly. The seal element may be provided in the form of a gasket.

The seal element may be compressible. The compression of the sealelement in the first position may be greater than the compression in thesecond position.

The seal element may be located in a seal element housing in one of thechamber wall or the movable insert. The seal element housing maycomprise a groove or channel provided within the chamber wall or movableinsert. The groove or channel may be provided in part by a radiallyouter wall, an axial end wall and/or one or more catheter guide featuresprovided within the storage chamber. The seal element may be overmouldedso as to become an integral part of the storage chamber or movableinsert. One or more of the sealing surfaces may be provided by the sealelement housing. The at least one sealing surface may slideably opposethe seal element. The at least one sealing surface may be referred to asa primary sealing surface.

The catheter assembly may further comprise a wetting agent. When in thesecond position, the wetting agent may be sealed within the storagechamber by the seal element maintaining a sealing contact with asecondary sealing surface adjacent to the (primary) sealing surface.Alternatively, in some embodiments, when in the second position, a flowpath may be provided between the sealing surface and seal element suchthat the wetting agent may flow out of the storage chamber when in thesecond position.

At least one of the movable insert and the chamber wall may comprise adivergent portion over which the seal element passes when transitioningbetween the first position and second position such that the distancebetween the chamber wall and movable insert at the axial location of theseal element is increased when in the second position when compared tothe first position. The distance may be a radial distance with respectto the longitudinal axis. The divergent portion may comprise a wideningof a cavity adjacent to the seal surface. The cavity may be that of thestorage chamber and/or an adjacent chamber. The adjacent chamber may beprovided within the main body. The adjacent chamber may house a cathetertube. The adjacent chamber may be a priming chamber or a wettingchamber.

The divergent portion may comprise a step, taper or chamfer in the wallsurface which is adjacent to the sealing surface. The sealing surfacemay comprise a cylindrical surface having a first diameter. An adjacentwall portion of the chamber wall or movable insert may have a seconddiameter which is different to the first diameter. The first diametermay be greater than the second diameter. The adjacent wall portion maybe proximal an insertion end of the catheter. The adjacent wall portionmay be a secondary surface.

The at least one sealing surface may be a primary sealing surface. Theportion of the chamber wall or movable insert comprising the seconddiameter may be a secondary sealing surface. Thus, when in the secondposition, the seal element may contact and seal against the secondarysealing surface. The contact pressure between the secondary sealingsurface and seal element may be reduced due to the increased separationbetween the movable insert and chamber wall at the location of thesecondary seal surface and seal element. That is, the seal element maybe provided in a compressed state in the first position and adecompressed state in the second position.

The catheter may be located within the storage chamber. The catheter maybe co-axially nested within with the storage chamber. The catheter maybe nested within a/the chamber wall so as to provide part of the storagechamber. The catheter may sealably extend through the chamber viaopenings in the axially opposed ends of the storage chamber.

The movable insert may be configured to move with respect to the chamberwall to a third position in which the catheter is wetted with thewetting agent. The movable insert may be configured to move in a firstdirection from the first position to the second position and from thesecond position to the third position. The first direction may be arotational direction and/or axial direction. The movable insert may movein a second direction from the first position to the second position anda third direction from the second position to the third position. Thesecond and third directions may be opposite to one another. The secondand third directions may be axial. The movable insert may be configuredto move rotationally and axially simultaneously.

The catheter assembly may further comprise a wetting chamber. Thewetting chamber may be located radially inwards of the storage chamber.The catheter may be coaxially nested within the wetting chamber. Theexternal housing, storage chamber, wetting chamber and catheter may beconcentrically arranged and axially aligned on the longitudinal axis.

The catheter assembly may further comprise a priming chamber. Thepriming chamber being in flow series with the storage chamber andwetting chamber. The priming chamber may be located proximally of thestorage chamber and the welling chamber. The priming chamber and/orwetting chamber may be separated from the storage chamber by the sealelement. The priming chamber may receive the wetting agent from thestorage chamber prior to being pumped into the wetting chamber.

The storage chamber and wetting chamber may be separate chambers. Thestorage chamber and wetting chamber may be separated by an internalhousing. The internal housing may be located in a spaced relation withinthe external housing to provide the storage chamber.

The storage chamber may be the wetting chamber. The wetting chamber maybe defined as a cavity within the catheter assembly from which a wettingagent is able to contact an external surface of a catheter tube. Thewetting agent may be applied to the catheter tube upon withdrawal of thecatheter tube from the storage chamber, in which case the storagechamber can be considered to be or comprise the wetting chamber.

Alternatively, where the storage chamber and wetting chambers areseparate chambers, the wetting agent may flow and/or may be pumped toand/or along the length of the wetting chamber and catheter tube. Insuch a case, the wetting agent may flow past the seal element. A primingchamber may be located between the storage chamber and wetting chamberand receive the wetting agent prior to it being passed along the wettingchamber. The priming chamber may be provided in the proximal end of themain body of the external housing.

When in the second position, the seal element may maintain a sealbetween the chamber wall and movable insert. When in the secondposition, the seal element may be separated from at least one of thesealing surfaces so as to provide a flow path for the wetting agent topass the seal element.

The wetting agent may be provided within the welling chamber when in thesecond position and/or a priming chamber.

The movable insert may comprise an internal housing. The internalhousing may be the housing which defines the storage chamber and wettingchamber.

The catheter assembly may comprise a plurality of seals. The pluralityof seals may comprise a proximal seal which is proximal to an insertionend of the catheter. The plurality of seals may comprise a second seal.The second seal may be axially separated from the proximal seal on thedistal side thereof. The distal seal and proximal seal may be locatedradially between the movable insert and chamber wall. The distal sealand proximal seal may comprise respective distal and proximal sealelements and sealing surfaces.

The distal seal may maintain sealing contact in the first and secondpositions.

The catheter assembly may further comprise a pump configured to pump thewetting agent into the wetting chamber. The movable insert may comprisethe pump. The internal housing may comprise the pump. The internalhousing may comprise one or more pump enhancing features. The internalhousing may comprise a plurality of circumferentially extending fins.The movable insert may be movable from the second position to the firstposition to pump the wetting agent into the wetting chamber.

The catheter may comprise a catheter tube which provides an insertionend for inserting into a patient and an outlet end comprising one ormore external handling features.

The movable insert may be provided by the catheter. For example aportion of the catheter may provide the moveable insert. The portion ofthe catheter may be a portion other than the catheter tube, for example,a funnel or an additional body. The storage chamber may be adjacent tothe outlet end of the catheter.

The catheter assembly may further comprise an actuator to move themovable insert relative to the storage chamber. The actuator may bereferred to as a priming mechanism herein. The actuator may comprise arotatable actuator. Rotating the rotatable actuator may move the movableinsert relative to the chamber wall. The movement of the movable insertmay be either or both of a rotational movement and an axial movement.The axial movement may be induced by the rotation of the rotationalactuator. Rotation of the rotatable actuator may be converted into theaxial movement between the movable insert and the chamber wall.

The catheter assembly may further comprise a cam drive for convertingthe rotation of the rotatable actuator into the axial movement. Thecatheter assembly may further comprise a screw thread for converting therotation of the rotatable actuator into the axial movement. The camdrive may comprise a screw thread or a portion of a screw thread. Theactuator may comprise one or more drive surfaces and one or morecorresponding driving elements which drivably engage with one another toprovide the rotational-axial movement.

The catheter assembly may further comprise an external housing whichcomprises a removable cap. The rotatable actuator may comprise the cap.

The cap may rotatably engage with the movable insert such that rotatingthe cap rotates the movable insert.

The movable insert may be configured to reciprocate upon rotation of therotatable actuator.

The second position may be a wetting position in which the catheter isconfigured to be wetted by the wetting agent. Thus, when in the secondposition, the wetting agent may be in flow communication with anexternal surface of the catheter tube. The second position may be aprimed position. When in the primed position, the catheter may beconfigured to be withdrawn from the storage chamber. In someembodiments, the primed position may correspond to a pre-pumpconfiguration in which the wetting agent is pumped or otherwise movedinto a wetting chamber.

An aspect of the present disclosure provides a catheter assemblycomprising a wetting mechanism. The catheter assembly may have at leasta two-step deployment. The two-step deployment may comprise: a firststep which breaks a hermetic seal and at least primes the wettingmechanism, putting the catheter assembly into a leak-resistant primedconfiguration; and a second step which removes a catheter tube from thecatheter assembly. The first stage and/or second step may additionallywet the catheter tube.

An aspect of the present disclosure provides a catheter assemblycomprising: a catheter and a housing having an internal cavity in whichthe catheter is housed. The housing may be an external housing. Thehousing may comprise a hermetic seal for preserving the sterility of theinternal cavity prior to use. A welling agent chamber may be located inthe internal cavity.

An aspect of the present disclosure may provide a catheter assemblycomprising: a catheter. The catheter assembly may further comprise anexternal housing having an internal volume in which the catheter ishoused. The external housing may comprise a hermetic seal for preservingthe sterility of the internal volume prior to use. The catheter assemblymay comprise a wetting agent chamber which may comprise one or morewetting agent seals for retaining the wetting agent within the wettingagent chamber. The catheter assembly may be configurable to comprise: ahermetically sealed configuration in which the hermetical seal is sealedand the wetting agent seal is sealed, and a primed configuration inwhich the hermetic seal is open and the one or more wetting agent sealsare sealed.

An aspect of the present disclosure provides a catheter assemblycomprising: a catheter; a housing having an internal cavity in which thecatheter is housed, the housing comprising a hermetic seal forpreserving the sterility of the internal cavity prior to use; a wettingagent chamber located in the internal cavity; and, wherein the catheterassembly is configured to deploy the catheter in a first step and asubsequent second step, wherein the first step comprises breaking thehermetic seal and priming the wetting agent chamber to put the catheterassembly into a leak-resistant primed configuration in which thecatheter is configured to be wettable with the wetting agent; and, thesecond step comprises removing the catheter from the housing.

Providing a sealed configuration in which the sterility of the internalvolume is preserved and a primed configuration in which the catheterassembly is retained in a potentially non-sterile but leak-resistantprimed configuration allows the deployment of the catheter to beinterrupted without risk of the wetting agent leaking out of thecatheter assembly. This is advantageous if a user is required totemporarily put the catheter down prior to withdrawing the catheter butafter breaking the hermetic seal.

The housing may comprise an external housing. The external housing maycomprise a main body and a cap. The hermetic seal may be attached to themain body and/or cap. The hermetic seal may attach the cap to the mainbody. The hermetic seal may comprise an external surface of the catheterassembly. Thus, the external housing may comprise a cap, a main body anda hermetic seal. The hermetic seal may be a tear strip which is brokenin use such that the cap is removable by hand. The hermetic seal may bebroken and the wetting agent primed by rotation of the cap relative tothe main body.

The first step and/or the second step may additionally wet a cathetertube of the catheter. Thus, placing the catheter assembly in a primedconfiguration may wet the catheter without the wetting agent being inflow communication with the exterior of the catheter assembly.Additionally or alternatively, the leak-resistant state may prevent flowcommunication between the wetting agent and a portion of the catheterwhich comprises a handling surface which is handled by a user in use.Thus, the handling surface may be maintained in a dry state prior to thecatheter being removed from the housing. The handling surface may beprovided by an outlet end of the catheter.

The catheter may be an intermittent catheter. The catheter may be aurinary catheter. The catheter may be a female intermittent catheter.

The catheter assembly may further comprise a priming mechanism. Thepriming mechanism may be referred to as actuator herein. The primingmechanism may be configured to carry out the first step with a singleuser action. Thus, a user may manipulate the priming mechanism bymoving, for example, rotating or pulling a part of the catheter assemblyto break the hermetic seal and prime the catheter assembly with a singleaction or movement. The first step may comprise simultaneously breakingthe hermetic seal and priming the wetting agent chamber to put thecatheter assembly into a leak-resistant primed configuration.

The housing may be an external housing. The housing may be rigid. Thehousing may comprise a cap and a main body. The cap and main body mayremain engaged during the first step. The engagement of the cap and mainbody may be a mechanical engagement in which the cap is attached to themain body either directly or indirectly. For example, the cap may beattached to the main body via an internal housing or some otherintermediate member.

The priming mechanism may comprise the cap. The cap may be drivablyrotatable relative to the main body such that drivably rotating the capbreaks the hermetic seal and primes the wetting agent chamber.

The priming mechanism may comprise: a drive surface, and a drivingelement which engages with the drive surface such that rotationalmovement of the driving element or drive surface causes the other ofdriving element or drive surface to axially translate, or vice versa.

The drive surface may extend axially and circumferentially. The drivesurface may comprise a ramp and/or helical surface. The drive surfacemay comprise a first axially facing surface provided by a radiallyprojecting flange, rib, thread, track or rail, or an end wall surface.

The driving element may comprise a second axially facing surface of aradially extending flange, rib, thread, track, rail or pin, or an endwall surface.

The end wall surface may be an end wall surface of the chamber wall.

The driving element and drive surface may be collectively referred to asa cam drive.

The priming mechanism may comprise a movable insert which partiallydefines the wetting agent chamber. The movable insert may be configuredto move between a sealed configuration and a primed configuration duringthe first step. The movable insert may be configured to move axiallywhen rotated.

The wetting agent chamber may comprise a wetting agent storage chamber.Additionally, or alternatively, the wetting agent chamber may comprise awetting chamber and/or a priming chamber. The wetting agent chamber maycomprise a chamber wall and the movable insert.

Either the chamber wall or movable insert may comprise the drivingelement or drive surface. The other of the chamber wall and movableinsert may comprise the other of the driving element and drive surface.

The driving element may comprise a plug for plugging an aperture. Theaperture may be a filling aperture. The filling aperture may be providedin an external wall of the housing.

The movable insert may be configured to move axially when rotated. Thecap may be rotatably engaged with the movable insert such that rotatingthe cap rotates and axially translates the movable insert.

The rotatable engagement between the cap and movable insert maydisengage following the first step. The disengagement of the rotatableengagement may be induced by a further rotation of the cap. Thus, a usermay rotate the cap in a first direction to prime the catheter assemblyand further rotate the cap in the first direction to disengage the cap.The disengagement of the rotatable engagement may configure the cap forremoval from the catheter assembly to expose the catheter forwithdrawing.

The movable insert may be provided by the catheter (as outlined above).

The movable insert may comprise an internal housing located radiallyinwards of the external housing. The catheter may be located radiallyinwards of the internal housing.

The internal housing may be located radially within the external housingso as to provide the storage chamber therebetween.

The catheter assembly may be configured to provide mechanical feedbackto a user. The mechanical feedback may be indicative of the end of thefirst step. The mechanical feedback may be between the first and secondsteps.

The first step may require a first actuating force and the second stepmay require a second actuating force. The first actuating force andsecond actuating force may be different. Thus, transitioning between thefirst and second actuating forces may provide a mechanical feedback forthe user. The first actuating force and second actuating force may beeither or both of: in different directions and different magnitudes.

The mechanical feedback may be provided by one or more stops in whichthe direction of actuation is required to change. Hence, the catheterassembly may comprise one or more limiters which limit the movement ofthe movable insert or an actuator associated with the movable insert.

The actuation of the catheter assembly required for the first and secondsteps may require the movement and/or removal of one or more parts.Thus, the first step may be actuated using the cap which is subsequentlyremoved, prior to the catheter being withdrawn axially by the user.

The wetting agent chamber may comprise a wetting agent storage chamber.In some embodiments, the wetting agent storage chamber may comprise aportion of the catheter. In some embodiments, the wetting agent chambermay comprise the storage chamber and/or a wetting chamber, and/or apriming chamber.

The wetting agent seal may be any seal or combination of seals which areused to seal the storage chamber, wetting chamber or priming chamber.The wetting agent seal may comprise a seal element and sealing surfaceas described herein.

In some embodiments, the catheter assembly may be configured to providethe wetting agent to a wetting chamber. The catheter assembly mayinclude a third configuration in which the hermetic seal is open and atleast one of the wetting agent seals is open.

The primed configuration may relate to the storage chamber being primedsuch that the catheter can be removed from within the storage chamberwhilst passing through the wetting agent provided therein.

The external housing may comprise a cap and a main body to which the capis attached. The attachment may be via the hermetic seal. Rotating thecap relative to the main body may break the hermetic seal.

The wetting agent chamber may comprise a wetting agent storage chamberwall and a movable insert. The wetting agent seal may be providedbetween the wetting agent storage chamber wall and the movable insert.The seal may comprise a seal element.

The catheter may comprise an insertable portion. Prior to the first stepthe insertable portion may not be in contact with the wetting agent.

It is advantageous that prior to deployment of the catheter, for exampleduring shipping and storage, that the insertable portion of the catheteris not in contact with the wetting agent. The insertable portion of thecatheter is often made of materials which interact with the wettingagent, this interaction should only occur just prior to use.

The catheter assembly may further comprise a wetting chamber. Thewetting agent may be in fluid communication with the wetting chamberwhen the catheter assembly is in the primed configuration. The wettingagent may be in the wetting chamber when in the third position.

The catheter assembly may further comprise a wetting chamber sealprovided between the storage chamber and wetting chamber. The wettingchamber seal may be open when the catheter assembly is in the primedconfiguration.

The movable insert may be an internal housing in which the catheter islocated. The movable insert may be the catheter. The catheter may beconfigured to be withdrawn from the wetting agent chamber and externalhousing when the catheter assembly is in the primed configuration.

The catheter assembly may further comprise an actuator to move themovable insert relative to the wetting agent chamber wall. The actuatormay comprise a rotatable actuator. Rotation of the rotatable actuatormay be converted into the axial movement between the movable insert andthe chamber wall.

The catheter assembly may further comprise a cam drive for convertingthe rotation of the rotatable actuator into the axial movement. Thecatheter assembly may further comprise a screw thread for converting therotation of the rotatable actuator into the axial movement. The catheterassembly may further comprise a cap, wherein the rotatable actuatorcomprises the cap. The cap may be rotatably engaged with the movableinsert such that rotating the cap rotates the movable insert.

The cap may be rotatably engaged with the movable insert such thatrotating the cap rotates the movable insert. Rotating or pulling the capmay break the hermetic seal.

Further rotating the cap or withdrawing the catheter may open the atleast one welling agent seal. The further rotation of the cap may be thesame rotation which breaks the hermetic seal.

An aspect of the disclosure provides a catheter assembly comprising: acatheter having a distal outlet end and a proximal insertion end. Thecatheter assembly may further comprise a wetting agent storage chamberand a housing. The housing may be an external housing. The externalhousing may at least partially enclose the catheter and the storagechamber. The catheter assembly may further comprise a sheath connectedbetween the catheter and the storage chamber such that withdrawing thecatheter from the external housing causes withdrawal of the storagechamber from the external housing via the sheath.

An aspect of the disclosure provides a catheter assembly comprising: acatheter having a distal outlet end and a proximal insertion end; awetting agent storage chamber; an external housing, the external housingat least partially enclosing the catheter and the storage chamber; and,a sheath connected between the catheter and the storage chamber suchthat withdrawing the catheter from the external housing causeswithdrawal of the storage chamber from the external housing via thesheath.

Providing a sheath connected between the catheter and storage chamberprovides a convenient way to remove the storage chamber from thecatheter following the catheter being withdrawn through the storagechamber. Hence, a catheter tube which is insertable into a patient maybe wetted with wetting agent stored in the storage chamber whilst thecatheter is withdrawn from the housing, prior to/during sheathing thewithdrawn catheter tube to help maintain the sterility of the cathetertube prior to insertion into the patient. Moreover, as the catheter isthen introduced into the urethra it may pass through the wetting agentstorage chamber for a second time, improving the wetting of the surfaceof the catheter.

Further, the provision of wetting mechanism which can be withdrawn fromthe external housing by the sheath allows the user to handle the wettedcatheter tube by the storage chamber without risking contamination ofthe catheter tube. Providing the storage chamber as an insertion guidein this way provides an efficient way to use the space in the externalhousing and allow for a greater supply of wetting agent.

The sheath may be a retractable sheath. The retractable sheath may bestowed in a stowed configuration and deployed to an extendedconfiguration. The sheath may be deployable from a stowed configurationin which the sheath is furled between the outlet end and storagechamber, to an extended configuration in which the sheath is unfurledand contains a catheter tube of the catheter located therein.

The catheter and storage chamber may be held within e.g. attached to)the external housing such that a first predetermined force is requiredto withdraw the catheter from the external housing and a secondpredetermined force is required to disengage the storage chamber forwithdrawal from the external housing. The first and second predeterminedforces may be different. The second predetermined force may be greaterthat the first predetermined force.

The catheter assembly may further comprise an insertion guide which isdeployable to the insertion end of the catheter for use. The insertionguide may comprise an external handling surface and be configured to aidthe placement of the insertion end at the urethra of a patient. Thestorage chamber may comprise the insertion guide.

The catheter assembly may further comprise a release mechanism arrangedto releasably retain the storage chamber.

The release mechanism may comprise a releasable coupling between theexternal housing and storage chamber. The release mechanism may providemechanical feedback for a user withdrawing the catheter and/or storagechamber. Thus, the release mechanism may require a predetermined amountof force to actuate the releasable coupling. The predetermined amount offorce may be the second predetermined force.

The releasable coupling may comprise one or more projections extendingfrom either or both the external housing and wetting agent chamber. Theprojections may be received in one or more corresponding recessesprovided in the other of the external housing and wetting agent chamber.

There may be an equal number of releasable projections and recesses. Theprojections and recesses may be configured to remain engaged whensubjected to the first predetermined force and configured to disengagewhen subject to the second predetermined force.

The first and second predetermined forces may be axial forces. The axialforces may be applied by a user via the catheter.

The projections may be elongate having a longitudinal axis. Theprojections may be configured to deflect away from the longitudinal axiswhen the second predetermined force is applied or is exceeded.

The catheter may be elongate and may define a principal longitudinalaxis of the catheter assembly. The longitudinal axis of the projectionsmay extend in the direction of the principal longitudinal axis.

The catheter assembly may comprise a plurality of projections andrecesses distributed circumferentially about the principal axis. Theplurality of projections and recesses may combine to provide an annularclasp.

The deflection of the projections may be in a radially outwardsdirection.

The release mechanism may be configured to prevent relative rotation ofthe external housing and wetting agent chamber. Thus, rotating a movableinsert within or which forms part of the storage chamber may not resultin relative rotation between the storage chamber and external housing.

The catheter assembly may further comprise a seal element in the storagechamber and a movable insert received within the storage chamber. Theseal element may be located between the storage chamber and movableinsert and may be radially inwards and axially aligned with theplurality of projections and/or recesses. Axially aligning position ofthe seal element and the releasable coupling which positions the storagechamber relative to the housing may help maintain the seal provided bythe seal element.

An aspect of the present disclosure provides a catheter assemblycomprising: a catheter; and a wetting agent storage chamber in which thecatheter is located. The wetting agent storage chamber may comprise atleast one projection configured to guide the catheter within the wettingchamber.

The at least one projection may guide the catheter within the wettingchamber during a withdrawal of the catheter. The at least one projectionmay guide the catheter within the wetting chamber during a reinsertionof the catheter through the wetting chamber.

An aspect of the present disclosure provides a catheter assemblycomprising a catheter; and a wetting agent storage chamber in which thecatheter is located, wherein the wetting agent storage chamber comprisesat least one projection configured to guide the catheter within thewetting chamber, wherein the at least one projection retains a sealelement in the wetting agent storage chamber.

Providing a storage chamber having one or more features such as aprojection to locate the catheter within the wetting chamber duringwithdrawal or reinsertion allows the positioning of the catheter to becontrolled which provides for an improved wetting of a catheter tube ofthe catheter. During reinsertion it also ensures the catheter does notbecome trapped within the wetting agent storage chamber.

An aspect of the disclosure provides a catheter assembly comprising: acatheter; and a wetting agent storage chamber in which the catheter islocated. The wetting agent storage chamber may comprise at least oneprojection configured to retain a seal element within the wetting agentstorage chamber. The at least one projection may be configured to retainthe seal element within the wetting agent storage chamber duringwithdrawal of the catheter.

As such, an aspect of the present disclosure provides a catheterassembly comprising a catheter; and a wetting agent storage chamber inwhich the catheter is located, wherein the wetting agent storage chambercomprises at least one projection configured to guide the catheterwithin the wetting agent storage chamber, wherein the at least oneprojection retains a seal element in the wetting agent storage chamberduring withdrawal of the catheter.

Providing a wetting agent storage chamber having one or more featuressuch as a projection to locate a seal element therein can provide aconvenient way to locate the seal element and maintain its relation tothe wetting agent storage chamber during withdrawal of a catheter of thecatheter assembly. This is beneficial as it ensures the seal element iscorrectly located upon reinsertion of the catheter into the wettingagent storage chamber, ensuring a seal is maintained after reinsertion.It also avoids the seal element being carried out on the catheter, whichwould obviously cause problems on insertion of the catheter into theurethra.

The at least one projection configured to retain the seal element withinthe wetting chamber may be the at least one projection configured toguide the catheter withing the wetting chamber.

The at least one projection may comprise a plurality of ribs or fins.The plurality of ribs or fins may extend axially and radially. The atleast one projection may comprise a plurality of pins. The at least oneprojection may comprise a plurality of pedestals. The at least oneprojection may comprise a plurality of flanges. The plurality ofprojections may comprise any combination of ribs and/or fins and/or pinsand/or pedestals and/or flanges.

The storage chamber may comprise an axially extending radially outerwall and at least one radially extending end wall. The storage chambermay comprise a first radially extending end wall and a second radiallyextending end wall. The end walls may comprise one or more tubularflanges extending axially therefrom.

The plurality of projections may extend from either or both of theradially outer wall or the at least one end wall. The plurality ofprojections may extend radially inwards from the radially outer wall ofthe wetting agent storage chamber. The plurality of projections may becircumferentially distributed. There may be at least 2 projections.There may be at least 3 projections. There may be at least 4projections. There may be at least 6 projections. There may be at least8 projections. There may be 4 projections.

The catheter and storage chamber may be concentrically aligned.

The projections may be shaped to define a void. The void may be definedby a discontinuity in the projections. The projections may onlypartially extend along the axial extent of the storage chamber. The voidmay be partially defined by an axial edge of the projections. The voidmay be partially defined by an end wall of the storage chamber. Thediscontinuity may be provided by a first portion of each projectionextending radially inwards by a first amount and a second portion ofeach projection extending radially inwards by a second, lesser amount.

The wetting agent storage chamber may comprise at least one radiallyextending end wall and at least one projection extending axially withinthe wetting agent storage chamber, the at least one projectionterminating short of the end wall to define a void.

As such, an aspect of the present disclosure provides a catheterassembly comprising a catheter; and a wetting agent storage chamber inwhich the catheter is located, wherein the wetting agent storage chambercomprises at least one projection configured to guide the catheterwithin the wetting agent storage chamber, wherein the at least oneprojection retains a seal element in the wetting agent storage chamber,wherein the chamber comprises at least one radially extending end walland at least one projection extending axially within the wetting agentstorage chamber, the at least one projection terminating short of theend wall to define a void.

The catheter may define a longitudinal axis and the each of theplurality of projections may lie in a plane defined by the longitudinalaxis. The plurality of projections may be provided in diametricallyopposing pairs.

The seal element may be elastomeric. The seal element may be annular.The seal element may be an O-ring. The seal element may be an X-ring orsimilar annular seal device. The seal element may be a U-cup seal.

As such, an aspect of the present disclosure provides a catheterassembly comprising a catheter; and a welling agent storage chamber inwhich the catheter is located, wherein the wetting agent storage chambercomprises at least one projection configured to guide the catheterwithin the wetting agent storage chamber, wherein the at least oneprojection retains a seal element in the wetting agent storage chamberand wherein the seal element is an O-ring.

The O-ring may be arranged in the void. The void may define a seat forthe seal element. The axial edges of the projections may define a seatfor the seal element. The seat may axially restrain the seal elementduring transition of the catheter from a stowed position to a wettingposition. The seat may axially restrain the seal element duringwithdrawal of the catheter. This is beneficial as it ensures the sealelement is correctly located upon reinsertion of the catheter into thewetting agent storage chamber, ensuring a seal is maintained afterreinsertion. It also avoids the seal element being carried out on thecatheter, which would obviously cause problems on insertion of thecatheter into the urethra.

The wetting agent storage chamber may comprise two openings arranged atopposing axial ends of the wetting agent storage chamber through whichthe catheter may pass. The projections may define a channel between thetwo openings.

As such, an aspect of the present disclosure provides a catheterassembly comprising a catheter; and a wetting agent storage chamber inwhich the catheter is located, wherein the wetting agent storage chambercomprises at least one projection configured to guide the catheterwithin the wetting agent storage chamber, wherein the at least oneprojection retains a seal element in the wetting agent storage chamberand wherein the wetting agent storage chamber comprises two openingsarranged on opposing axial ends of the wetting agent storage chamberthrough which the catheter passes, the projections defining a channelbetween the two openings.

The radially inner edges of the projections may define a guide forguiding the passage of the catheter during a withdrawal orre-passing/re-insertion of the catheter. The guide may extend at least50% of the distance between the two openings, preferably the guide mayextend at least 80% of the distance between the two openings. The guidemay extend at least 40% of the distance between the two openings. Theguide may extend at least 50% of the distance between the two openings.The guide may extend at least 60% of the distance between the twoopenings. The guide may extend at least 70% of the distance between thetwo openings.

The separation between the radially inner edges of adjacent projectionsmay be less than the diameter of the catheter. By ensuring theseparation between the radially inner edges of adjacent protectionsbeing less than the diameter of the catheter, the catheter is restrictedfrom deviating from the channel defined by the projections.

As such, an aspect of the present disclosure provides a catheterassembly comprising a catheter; and a wetting agent storage chamber inwhich the catheter is located, wherein the wetting agent storage chambercomprises at least one projection configured to guide the catheterwithin the wetting agent storage chamber, wherein the at least oneprojection retains a seal element in the wetting agent storage chamberand wherein the radially inner edges of the projections define a guidefor guiding the passage of the catheter during a withdrawal of thecatheter, and wherein the separation between the radially inner edges ofthe adjacent projections is less than the diameter of the catheter.

The diameter of the guide may be approximately equal to the diameter ofone or more openings of the wetting chamber. The diameter of the guidemay be approximately equal to the diameter of sealing surface of themoveable insert. The diameter of the guide may be larger than thediameter of sealing surface of the moveable insert.

An aspect of the invention provides a catheter assembly comprising: anexternal housing; a catheter located within the external housing; and amovable insert. The movable insert may be an internal housing arrangedbetween the external housing and the catheter. An outer surface of theinternal housing and an inner surface of the external housing maytogether define a wetting agent storage chamber.

An aspect of the invention provides a catheter assembly comprising: anexternal housing; a catheter located within the external housing; amovable insert comprising an internal housing arranged between theexternal housing and the catheter, wherein an outer surface of theinternal housing and an inner surface of the external housing togetherdefine a wetting agent storage chamber.

Providing an internal housing between an external housing and thecatheter may provide an advantageous location for the storage of thewetting agent. Such a location may provide a large volume for thewetting agent. Further, the location adjacent the external housing mayprovide a convenient location for filling purposes following theassembly of the catheter assembly. The internal housing may alsoadvantageously be used to provide a wetting chamber around the catheter.

The internal housing may comprise an elongate tubular member. Theelongate tubular member may be concentrically mounted within theexternal housing.

The internal housing may be located in a radially spaced relation withinthe external housing to provide the storage chamber therebetween. Eitheror both of the internal housing and external housing may comprise atleast one projection extending between the internal housing and theexternal housing.

The at least one projection may be an elongate rib. The at least oneprojection may extend circumferentially around the internal housing.

The at least one projection may include an axial flow passagetherethrough. The at least one projection may extend only partiallyaround the internal housing to provide an axial flow passage therepast.The at least one projection may comprise an annular rib. The annular ribmay be discontinuous so as to provide a flow passage therethrough. Theaxial flow passage allows the projections to extend between the internalhousing and external housing to aid positioning of the internal housingwithin the external housing whilst still allowing fluid to flow alongthe length of the storage chamber. Additionally or alternatively, theflow passage may control the extent of the axial flow such that theinternal housing may be utilised as a pump.

The catheter assembly may comprise a plurality of projections. Theplurality of projections may be distributed axially along the length ofthe internal housing or external housing.

The at least one projection may extend from the internal housing so asto be movable in relation to the external housing. Moving the internalhousing and projection(s) axially along the longitudinal axis againstwetting agent will cause the at least one projection to urge the wettingagent in the direction of travel. Thus, the at least one projection maybe configured to pump the wetting fluid out of the storage chamberduring axial movement of the internal housing.

The at least one projection may extend between the external housing andinternal housing with a minimum clearance. Hence, at least oneprojection may be configured to radially locate the internal housingwhilst permitting axial movement therein.

The external housing may comprise a filling aperture in flowcommunication with the storage chamber. The external housing maycomprise a cap and a main body. The filling aperture may be provided inan external wall of the main body. The filling aperture may beconfigured to receive a plug. The catheter assembly may further comprisethe plug.

The catheter assembly may further comprise an actuator for moving theinternal housing. The actuator may be referred to as a primingmechanism. The actuator may comprise a driving surface against which adriving element acts to move the internal housing. The driving elementmay comprise the plug.

Either of the driving element or drive surface may be provided on eitherof a chamber wall of the storage chamber or the movable insert receivedwithin the chamber wall. The other of the driving element and drivesurface may be provided on the other of the chamber wall and movableinsert. The drive surface and driving element may be configured suchthat relative rotation of the movable insert and chamber wall results inaxial movement of the movable insert or chamber wall.

The catheter assembly may further comprise a wetting agent within thestorage chamber and contacting the external housing and internalhousing.

The movable insert may be movable between a sealed configuration and aprimed configuration. During movement to the primed configuration, thestorage chamber may be open to provide a flow path for the wetting agentto exit the storage chamber. The flow path may extend into a primingchamber or a wetting chamber in which the catheter is located.

The catheter assembly may comprise one or more vents. The storagechamber may comprise the one or more vents. The one or more vents may beair inlet vents configured to allow gas to enter the storage chamber toreplace the wetting agent as it exits the storage chamber. The one ormore vents may be internal to the external housing or external to theexternal housing. Movement of the movable insert may open the one ormore vents. Moving the movable insert from a sealed configuration to anopen configuration may open the one or more vents. Moving the movableinsert from a sealed configuration to the primed configuration may openthe one or more vents. The one or more vents and flow path opening maybe arranged at axially opposing ends of the storage chamber.

The flow path may be provided by opening a seal which defines thestorage chamber. The seal may be a proximal seal.

The outer surface of the movable insert may be an outer peripheralsurface. The outer surface of the movable insert may be an outercircumferential surface. The inner surface of the external housing maybe an inner circumferential surface.

An aspect of this disclosure provides a catheter assembly comprising anexternal housing, the external housing comprising a filling aperture anda wetting agent storage chamber. The filling aperture may be in flowcommunication with the storage chamber. The filling aperture may beconfigured to allow the catheter assembly to be assembled prior to thestorage chamber being filled with wetting agent.

An aspect of the disclosure provides a catheter assembly comprising anexternal housing, the external housing comprising a filling aperture anda wetting agent storage chamber, the filling aperture being in flowcommunication with the storage chamber; wherein the filling aperture isconfigured to allow the catheter assembly to be assembled prior to thestorage chamber being filled with wetting agent.

Providing a filling aperture in an external housing provides aconvenient location for the filling of the storage chamber. The aperturemay be conveniently plugged following a filling procedure to provide ahermetically sealed sterile assembly.

An aspect of this present disclosure may provide a method of assemblinga catheter assembly (in particular, for example, a catheter assembly asdefined immediately above), the method comprising: a) inserting acatheter tube and a wetting agent storage chamber into an interiorcavity of an external housing; b) filling the storage chamber with awetting agent via a filling aperture arranged on the external housing;c) sealing the external housing; and, d) sterilising the interiorcavity.

The steps a-d are preferably carried out in that order. Of coursefurther steps may also be included. Sealing the external housing maycomprise inserting a plug into the filling aperture. The plug maysubsequently be welded to the external housing.

Sealing the external housing may comprises putting a cap on the housing.Sealing the external housing may comprise hermetically sealing thehousing.

Sterilising may be irradiation sterilising, for example gammasterilising, x-ray sterilising or EB (electron beam) sterilising.

The external housing may comprise a cap and a main body. The externalhousing may comprise a filling aperture in flow communication with thestorage chamber. The external housing may comprise a cap and a mainbody. The filling aperture may be provided in an external wall of themain body. The filling aperture may be configured to receive a plug. Thecatheter assembly may further comprise the plug.

The catheter assembly may further comprise an actuator for moving theinternal housing. The actuator may be referred to as a primingmechanism. The actuator may comprise a drive surface against which adriving element acts to move the internal housing. The driving elementmay comprise the plug.

Either of the driving element or drive surface may be provided on eitherof a chamber wall of the storage chamber or the movable insert receivedwithin the chamber wall, and wherein the other of the driving elementand drive surface is provided on the other of the chamber wall andmovable insert. The drive surface and driving element may be configuredsuch that relative rotation of the movable insert and chamber wallresults in axial movement of the movable insert or chamber wall.

The movable insert may be the catheter.

The catheter assembly may further comprise an internal housing withinthe external housing. The storage chamber may be provided between and bedefined by the external housing and internal housing. The internalhousing may be a movable insert configured to move axially and/orrotationally with respect to the external housing.

The drive surface may comprise at least one drive surface outlet toprovide flow path between the filling aperture and storage chamber.

The drive surface may comprise at least one rail. The rail may comprisea discontinuity to provide a flow passage through the rail.

The drive surface may comprise a pair of axially spaced rails. Thespacing between the rails may correspond to the diameter of the drivingelement.

The internal housing may be located in a spaced relation within theexternal housing to provide the storage chamber. The internal housingmay comprise a plurality of ribs on a radially outer wall thereof so asto extend between the internal housing and the external housing.

The ribs may extend circumferentially. Each rib may include an axialflow passage therethrough.

An aspect of this disclosure may provide a catheter assembly having alongitudinal axis, the catheter assembly comprising: a catheter; awetting agent storage chamber; and an external housing in which thecatheter and storage chamber are housed. The storage chamber maycomprise a movable insert configured to move axially along thelongitudinal axis in relation to the external housing when the movableinsert is rotated.

An aspect of the disclosure may provide a catheter assembly having alongitudinal axis, the catheter assembly comprising: a catheter; awetting agent storage chamber; and, an external housing in which thecatheter and storage chamber are housed; wherein the storage chambercomprises a movable insert configured to move axially along thelongitudinal axis in relation to the external housing when the movableinsert is rotated.

Providing a movable insert which translates axially when rotated allowsthe storage chamber to be conveniently configured for use. For example,the movable insert may be configured to transform the storage chamberfrom a sealed configuration to a primed configuration by rotating themovable insert, thereby allowing the catheter assembly to be primed witha single action from a user.

The movable insert may be movable between a sealed configuration and aprimed configuration. The sealed configuration may correspond to aconfiguration in which the catheter assembly is sealed prior to use. Theseal may be a hermetic or sterile seal in which the internal cavity ofthe external housing is sterile, or a leak-resistant sealed condition inwhich the wetting agent is sealed within the internal cavity of theexternal housing to so as to prevent escape of the wetting agent. Theleak-resistant sealed condition may mean that the wetting agent issealed within one or more of a storage chamber, a wetting chamber and apriming chamber. The leak resistant sealed condition may mean thategress from the external housing is prevented, or wetting agentcontacting one or more handling surfaces of the catheter is prevented.

The primed configuration may correspond to a configuration in which thecatheter is ready to be wetted. Thus, when in the wetted configuration,the catheter may be configured to be withdrawn by a user. In someembodiments, (e.g. in the sealed configuration) a seal may retain thecatheter to restrict/prevent withdrawal. When in the primedconfiguration, the pressure exerted by the retaining seal on thecatheter may be reduced to allow the catheter to be sealably withdrawnfrom the storage chamber, thereby wetting a catheter tube of thecatheter. In some embodiments, the primed configuration may comprise anopening of a storage chamber seal such that a flow path between thestorage chamber and a subsequent chamber is opened.

The storage chamber may comprise a chamber wall. The movable insert andchamber wall may be sealably engaged to seal the storage chamber via aseal.

The movable insert may be located radially inwards of the chamber wall.The seal may comprise a seal element retained by the movable insert orthe chamber wall and an opposing sealing surface provided by the otherof the movable insert and chamber wall.

The seal element may be adapted to align with the sealing surface whenin the sealed configuration. The seal element may be adapted to beaxially misaligned with the sealing surface when in the primedconfiguration.

The seal element may comprise an elastomeric material. The seal elementmay be an O-ring. The seal element may be an X-ring. The seal elementmay be a U-cup seal.

The seal element may be located in a seal element housing provided bythe chamber wall or the movable insert.

At least one of the movable insert and the chamber wall may comprise adivergent portion over which the seal element passes when transitioningbetween the sealed configuration and primed configuration. As such thedistance between the chamber wall and movable insert at the axiallocation of the seal element may be increased when in the primedconfiguration.

The divergent portion may comprise a step, taper or chamfer adjacent tothe sealing surface.

The sealing surface may be a primary sealing surface. The catheterassembly may further comprise a secondary sealing surface. The sealelement may seal against the secondary sealing surface when in theprimed configuration.

The chamber wall or movable insert may comprise one or more axially andcircumferentially extending drive surfaces. The other of the chamberwall and movable insert may comprise a driving element which engageswith the drive surface to provide the axial movement of the movableinsert upon relative rotation of the movable insert and chamber wall.

The drive surface may comprise a first axially facing surface providedby a radially projecting flange, rib, thread, track or rail, or an endwall surface of the respective movable insert or chamber wall.

The driving element may comprise a second axially facing surface of aradially extending flange, rib, thread, track, rail or pin, or an endwall surface of the respective movable insert or chamber wall.

The driving element may comprise a plug for plugging an aperture. Theaperture may be a filling aperture. The filling aperture may be providedin an external wall of the external housing.

The drive surface may be provided by the chamber wall. The drive surfacemay be provided by an end wall surface of the chamber wall.

The movable insert may be movable between the primed configuration and awetted configuration.

The external housing may comprise a main body and a cap. The cap may berotatably engaged with the movable insert such that rotation of the caprotates the moving insert to provide the axial movement. The rotatableengagement may be provided by one or more interlocks which rotatablycouple the cap to the internal housing.

Rotating the cap may transition the movable insert from the sealedconfiguration to the primed configuration. Further rotating the cap maytransition the movable insert from the primed configuration to thewetted configuration. Rotating the cap may transition the movable insertfrom the sealed configuration to the wetted configuration.

The movable insert may be configured to axially reciprocate along thelongitudinal axis. The movable insert may be configured to reciprocatewhilst being rotated in a continuous common direction. The reciprocatingmovement may comprise a distal movement followed by a proximal movement.

The cap may be sealably attached to the main body via an externalhousing seal. The cap and seal may be configured such that the capbreaks the external housing seal. The external housing seal may be ahermetic seal.

The chamber seal may be a proximal seal. The catheter assembly mayfurther comprise a distal (chamber) seal. The distal seal and proximalseal may be axially spaced along the length of the movable insert andchamber wall to define a cavity for the wetting agent.

The distal seal may comprise a distal seal element and an opposingdistal seal surface, wherein the distal seal surface and distal sealelement are sealed in the sealed configuration and primed configuration.

The movable insert may be the catheter.

The movable insert may comprise an internal housing. The internalhousing may at least partially define the storage chamber and whereinthe catheter is located within the internal housing.

The internal housing may be located radially-within the external housingso as to provide the storage chamber therebetween.

The catheter assembly may further comprise a movable insert rotationlimiter. The rotation limiter may be configured to limit the rotation ofthe movable insert to less than a predetermined amount.

The internal housing may be rotatably attached to the cap via a torqueactivated release interlock. The release interlock may be configured torelease upon continued rotation of the movable insert when the movableinsert rotation limiter is engaged.

The drive surface may comprise a track. The track may be cosine shaped.

When the drive surface is a track, the track may extend between a firstend point and a second end point and have a mid-point therebetween. Thefirst end point and second end point may be axially distal relative tothe mid-point. The second end point may comprise the rotation limiter.

The track may extend circumferentially through at least 180 degrees andless than 360 degrees. The track may extend circumferentially for 270degrees. The cap may disengage from the movable insert after 270 degreesof rotation. The cap may be released from the catheter assembly after afurther 90 degrees of rotation. Thus, a single full rotation of the caprelative to the main body may transition the catheter assembly from asealed configuration to a primed configuration to an open/wettedconfiguration from which the catheter can be removed. The transitionfrom the sealed configuration to the primed configuration mayadditionally break a hermetic seal.

The external surface of the catheter may be provided in a wettingchamber which exists between an inner surface of the external housingand an external surface of the catheter; such a wetting chamber may bedefined by a sheath, or a sheath may be provided within the wettingchamber.

The catheter assembly may comprise a hermetic seal for preserving thesterility of the internal volume prior to use.

When in a sealed configuration, the hermetic seal may be intact. When ina primed or wetting configuration, the hermetic seal may be broken suchthat the internal volume of the external housing is at least partiallyopen to the external air such that sterile environment may be consideredbreached.

When in a sealed configuration, a wetting agent chamber may be sealed byone or more wetting agent seals. The wetting agent storage chamber maycomprise a wetting agent storage chamber and/or a priming chamber and/ora wetting chamber in which the catheter is located to be wetted.

When in a primed configuration and/or wetting configuration, the wettingagent seal may be intact so as to be sealed in a leak resistant mannerthereby preventing escape of the wetting agent to the exterior of thecatheter assembly or a catheter outlet end having external handlingsurfaces.

The catheter assembly may comprise a third configuration in which thehermetic seal is open and the wetting agent seal is open. When thewetting agent seal is open, the catheter may be configured to bewithdrawn from the external housing.

The external housing may comprise a cap and a main body to which the capis attached via the hermetic seal. The hermetic seal may comprise a tearstrip which is removed by hand prior to use such that the cap isremovable by hand. The hermetic seal may be broken by rotation of thecap relative to the main body.

The wetting agent chamber may comprise a wetting agent storage chamber.The storage chamber may comprise a chamber wall and a movable insert.The wetting agent seal may be provided between the wetting agent storagechamber wall and the movable insert.

The catheter assembly may further comprise a wetting chamber. Thewetting agent may be in fluid communication with the wetting chamberwhen the catheter assembly is in the primed configuration.

The catheter assembly may comprise a wetting chamber seal providedbetween the storage chamber and wetting chamber. The wetting chamberseal may be open when the catheter assembly is in the primedconfiguration.

The movable insert may be an internal housing in which the catheter islocated. The movable insert may be the catheter.

The catheter may be configured to be withdrawn from the wetting agentchamber and external housing when the catheter assembly is in the primedconfiguration.

Transitioning between the sealed configuration and the primedconfiguration may comprise moving the movable insert. The moving of themovable insert may comprise rotating the movable insert and/or movingthe movable insert axially.

The catheter assembly may comprise an actuator for moving the movableinsert. Optional features of the actuator are described herein.

The catheter comprises a catheter tube and an outlet body. The cathetermay comprise an insertion end for inserting into the patient and anoutlet end from which fluid is excreted during use. The outlet end maycomprise one or more flow enhancing features such as a funnel whichdiverges along the flow direction. The outlet end may comprise anexternal handling surface. The external handling surface may be exposedfor a user to handle when the cap is removed. The external handlingsurface may comprise one or more surface features to enhance a user'sgrip. The one or more surface features may comprise one or more grooves.The catheter tube may comprise one or more inlets for receiving urine atan insertion end thereof.

The catheter tube may be functionalised. For example it may comprise, beintegrated with or be coated with a hydrophilic component (e.g. ahydrophilic polymer). The hydrophilic component serves to reducefriction further upon application of the wetting agent. At least anexternal surface of the catheter tube may be functionalised, e.g. thehydrophilic component may be provided on at least an external surface ofthe catheter tube (which is in contact with the urethra in use). Thecatheter may comprise a main flow path for the passage of urine. Themain flow path may extend along and define a longitudinal axis of thecatheter. The main flow path may be provided by a wall of catheter tube.The main flow path may have a proximal inlet at an insertion end of thecatheter, and a distal outlet.

The catheter may comprise an outlet body. The outlet body mayincorporate the terminal end of the catheter tube. The outlet body maycomprise the external handling surface of the catheter. The outlet bodymay comprise one or more flow enhancing features for aiding the flowfrom catheter tube. The one or more flow enhancing features may comprisea funnel, for example.

The outlet body may comprise or be referred to as a connector whichconnects the outlet end, e.g. a funnel and/or the external handlingfeatures, and the catheter tube.

The external surface of the catheter may be provided in a wettingchamber which exists between an inner surface of the external housingand an external surface of the catheter tube.

The sheath may be a retractable sheath. The retractable sheath may beconfigured to be retracted during insertion of the catheter such that itprovides a temporary enclosure around the catheter tube prior toinsertion.

The sheath may provide a restraint for a retractable insertion guidewhich is provided at the proximal end of the catheter towards theinsertion end and used to locate the catheter tube at the entrance tothe urethra. The sheath may tether the insertion guide and/or storagechamber to the outlet end of the catheter such that withdrawal of thecatheter tube unfurls the sheath and a full withdrawal of the catheterfrom the external housing results in the insertion guide and/or storagechamber being withdrawn from the external housing.

The storage chamber may comprise the insertion guide. The insertionguide may be provided by the proximal end of the storage chamber.

The catheter assembly may comprise a wetting chamber which may bedefined by a sheath, or in which a sheath may be provided.

The storage chamber may comprise an annular chamber in which thecatheter is located. The storage chamber may be located at a distal endof the catheter. The storage chamber may surround the catheter betweenan outlet end of the catheter and the catheter tube. The catheter outletmay be connected to the catheter tube by a connection portion. Thecatheter, for example, the connection portion, may comprise one or moresealing surfaces against which a seal element may seal in use.

The storage chamber may comprise a chamber wall and a surface of thecatheter. The catheter may be a movable insert. The chamber \van maycomprise an axially extending radially outer wall. The chamber wall maycomprise end walls extending radially inwards from the radially outerwall towards the catheter. The end walls may comprise a radiallyextending portion and annular flanges extending along the catheter. Theannular flanges may comprise a reduced radius compared with the radiusof the radially outer wall.

The storage chamber may comprise a plurality of projections which definea guide tube through which the catheter passes. The plurality ofprojections may guide the catheter during withdrawal of the catheter soas to maintain concentricity. The plurality of projections may comprisea plurality of axially extending ribs. The plurality of projections mayextend from a distal end wall of the storage chamber wall. The pluralityof projections may extend radially inwards from the radially outer wall.The seal housing may be defined within the radially outer wall. The sealhousing may be defined by the plurality of projections and an end wallof the chamber wall.

The storage chamber may be configured to have a sealed position andprimed position. The sealed and primed positions may be referred to assealed and primed configurations. The sealed position may correspond tothe seal element being on the primary sealing surface. The primedposition may correspond to the seal element being on a second sealingsurface. The seal contact pressure may be greater in the sealed positionthan the seal contact pressure in the primed position.

The sealed configuration may correspond to a sealed configuration of thecatheter assembly in which the catheter assembly is hermetically sealedby a hermetic seal.

The storage chamber may comprise at least two seal elements which areaxially separated along the catheter so as to provide a distal sealcomprising a distal seal element and a proximal seal comprising aproximal seal element.

The distal seal element may be provided on a seal surface having aconstant profile between the sealed configuration and primedconfiguration and/or wetting configuration. The distal seal sealingsurface may be defined by one or more radial projections which define arecess in which the distal seal element is retained. The distal sealelement may be retained within the recess when the catheter is removedfrom the external housing.

The proximal seal may comprise a proximal seal surface. The proximalseal surface may be raised with respect to the proximal and/or distalportions of the seal surface. Thus, the proximal seal may comprise adivergent portion over which the seal element passes when transitioningbetween the sealed configuration and the primed configuration and/orwetting configuration such that the distance between the chamber walland movable insert at the axial location of the seal element isincreased when in the wetting configuration.

The proximal seal may be arranged in a proximal seal housing. Theproximal seal housing may be provided within the radially outer wall.The proximal seal housing may be provided by the plurality ofprojections and an end wall of the chamber wall.

The storage chamber may be configured to have a sealed position and oneor more of a primed position and wetting position. The sealed, primedand wetting positions may be referred to as configurations.Transitioning between the sealed configuration and primed configurationand/or wetting configurations may be achieved using an actuator. Theactuator may be referred to as a priming mechanism.

The actuator may comprise a rotatable actuator in which a user mayrotate a rotor, for example, a cap of the external housing or thecatheter to transition the catheter assembly and/or wetting agentchamber and/or storage chamber between sealed, primed and/or wettingconfigurations. Rotation of the rotatable actuator may be converted intothe axial movement between the movable insert and a chamber wall of thewetting agent storage chamber.

The actuator may comprise a drive surface which drivably engages with adriving element. The drive surface may comprise one or more helicalmembers which urge against a corresponding driving element so as todrive the movable insert axially in relation to the storage chamber. Thehelical members may be fins which extend circumferentially and axiallyaround the catheter. The drive surface and driving element may belocated towards the outlet end of the catheter.

The drive surface may extend only partially around the longitudinalaxis. For example, the drive surface may be extend around 90 degrees.There may be a plurality of circumferentially distributed drive surfacesmembers. The drive surface and driving element may be referred to as acam drive for converting the rotation of the rotatable actuator into theaxial movement.

The rotatable actuator may comprise the cap. The cap may be rotatablyengaged with the movable insert such that rotating the cap rotates themovable insert. The movable insert may be the catheter.

The cap may comprise one or more radially extending cap projectionswhich engage with corresponding radially extending catheter outlet endprojections to provide the rotational engagement. Either or both of thecap projections and the catheter outlet projections may be axiallyextending radial fins. Each of the fins may lie in a plane defined bythe longitudinal axis. The rotatable engagement between the cap andcatheter may be configured to allow axial movement such that the cap canbe removed axially from the rotatable engagement following a rotation ofthe cap though a predetermined angle.

The movable insert may be the internal housing. The internal housing maybe configured to move axially upon rotation of the rotatable actuator.The internal housing may be configured to reciprocate upon rotation ofthe rotatable actuator. Thus, rotating the rotatable actuator may movethe internal housing in a first axial direction followed by a secondaxial direction. The rotational direction of the rotating actuator maybe in the same direction. The first axial direction may be distal inrelation to the insertion end of the catheter. The second direction maybe proximal.

The driving surface may comprise a track which engages with a drivingelement. The track may be referred to as a plunger track. The track maybe provided on either the internal housing or main body of the externalhousing. The driving element may comprise a projection which may beprovided on the other of the internal housing and external housing.

The track and driving element may be provided within the storagechamber. The driving element may comprise a plug which is receivedwithin a filling orifice for the storage chamber. Thus, the main bodymay comprise at least one aperture extending through an external wallthereof, the aperture providing access to the storage chamber such thatthe wetting fluid may be received via the aperture. The aperture may beconfigured to receive the driving element following the fillingprocedure. Thus, the aperture may oppose the guide track in which thedriving element is received.

The track may extend from a first endpoint which corresponds to thesealed configuration, to a mid-point which corresponds to a primedconfiguration, to a third endpoint which corresponds to a wettedconfiguration. The track extends in a first circumferential directionand a first axial direction between the first end point and mid-point,and in the first circumferential direction and in a second axialdirection between the mid-point and end point. The first axial directionand second axial direction may oppose one another. The first axialdirection may be a proximal direction. The second axial direction may bea distal direction.

The track may be comprise one or more track walls. The track walls maybe discontinuous so as to provide an outlet for wetting agent in thetrack. Thus, the track may receive the wetting agent from a fillingaperture prior to flowing into the internal volume of the storagechamber.

Optional features set out above may apply to any aspect of theinvention. Thus, for example, the preferred length of the catheter andassembly is only described once above, but applies to all aspects andcombinations of aspects and other optional feature.

DETAILED DESCRIPTION OF THE INVENTION

In order that the invention may be more clearly understood one or moreembodiments thereof will now be described, by way of example only, withreference to the accompanying drawings, of which:

FIG. 1 a shows an exploded view of a catheter assembly according to anembodiment of the disclosure;

FIG. 1 b shows a side view of the catheter assembly of FIG. 1 in aclosed or sealed configuration;

FIGS. 2 a to 2 c show the steps of removing the cap from the catheterassembly and stowing the cap on the opposing end of the catheterassembly external housing;

FIG. 3 shows a longitudinal section of the catheter assembly of FIG. 1 ;

FIG. 4 shows an enlarged longitudinal sectional view of the proximal endof the catheter assembly of FIG. 3 detailing a storage chamber and awetting chamber;

FIG. 5 shows an enlarged longitudinal sectional view of the distal endof the catheter assembly of FIG. 3 ;

FIGS. 6 a to 6 c show a sequence of longitudinal sections of thecatheter assembly of FIG. 1 highlighting the wetting procedure for thecatheter;

FIG. 7 show a perspective view of an internal housing which may used inthe catheter assembly of FIG. 1 ;

FIGS. 8 a, and 8 b show, respectively, a side view and flattened frontview schematic of a plunger track provided by the internal housing ofFIG. 7 ;

FIGS. 9 a to 9 c show an upper portion of the internal housing anddetails of a cap which may be used with the catheter assembly shown inFIG. 1 ;

FIGS. 10 a , to 10 f show a sequence of side view images of the catheterassembly according to an embodiment of the invention demonstrating theprincipal steps for wetting and removing a catheter from the externalhousing;

FIG. 11 shows a longitudinally exploded view of a catheter assemblyaccording to an embodiment of the disclosure;

FIG. 12 shows a perspective view of the catheter assembly of FIG. 11 ;

FIG. 13 shows a partial cross-sectional view of the catheter assembly ofFIG. 11 showing a wetting agent storage chamber;

FIGS. 14 a and 14 b show schematic longitudinal sections of the catheterassembly of FIG. 13 in a sealed and primed configuration respectively;

FIG. 15 shows a longitudinally exploded view of a rotatable actuator,storage chamber and movable insert according to an embodiment;

FIGS. 16 a and 16 b show a storage chamber according to an embodiment;

FIGS. 17 and 18 show an example of a storage chamber and releasablecoupling;

FIG. 19 shows a partial longitudinal sectional view of a retractablesheath in a stowed configuration;

FIG. 20 shows an exploded view of a catheter assembly according to thepresent invention

FIG. 21 a shows a side view of a catheter assembly of FIG. 20 ;

FIG. 21 b shows a side view of the catheter assembly of FIG. 20 with thecase removed;

FIG. 21 c shows a side view of the catheter assembly of FIG. 20 ,including a sheath, with the case removed.

FIG. 22 a shows a cross sectional view of the wetting mechanism of thecatheter assembly of FIG. 20 in a closed configuration; and

FIG. 22 b shows a cross sectional view of the wetting mechanism of thecatheter assembly of FIG. 20 in an open configuration.

FIG. 1 shows an axially exploded view of a catheter assembly 10according to the present invention. The catheter assembly comprises anexternal housing 12, an internal housing 14 and a catheter 16. Theexternal housing 12, internal housing 14 and catheter 16 areconcentrically arranged such that the catheter 16 is located within theinternal housing 14 which is located within the external housing 12 in aradially nested configuration.

The catheter assembly 10 may be configured such that the catheter 16 maybe wetted prior to being withdrawn from the external housing 12. Thewetting agent used to wet the catheter 16 prior to use and may be heldin a wetting agent storage chamber which is defined between the externalhousing 12 and the internal housing 14. The wetting agent may bedelivered to the catheter 16 via a wetting chamber which is definedbetween the internal housing 14 and catheter. The wetting agent may bepumped or driven into the wetting chamber from the storage chamber. Thewetting agent may be water or some other suitable agent, as well knownin the art.

Referring to FIGS. 1 a, 1 b , 3, 4 and 9 b and 9 c, the external housing12 comprises a main body 18 in which a portion of the internal housing14 and catheter 16 are housed, and a cap 20 which is detachable so as tobe removable by a user prior to use of the catheter. Removing the cap 20may expose the catheter 16 such that it can be withdrawn from theexternal housing 12.

The external housing 12 provides an enclosed volume in which thecatheter 16 can be housed for storage and transportation prior to use.The main body 18 and cap 20 may provide a sterile cavity in which thecatheter 16 is located. The external housing 12 is generally elongatehaving a longitudinal axis 22 which can be taken to be the principalaxis of the catheter assembly 10 and also provide the longitudinal axisfor the internal housing 14 and catheter 16 etc. References to alongitudinal axis, axial or radial in this disclosure should be taken tobe with reference to the longitudinal axis 22 unless stated otherwise.

The enclosed volume provided by the external housing 12 is defined by anexternal wall of the housing 12 which extends from a first proximal end13, which receives an insertion end 24 of the catheter 16, to a seconddistal end 15 in which a catheter outlet end 26 is received. In theembodiment shown, the second end 15 is provided by the cap 20. Thus, theremoval of the cap 20 exposes the outlet end 26 of the catheter 16 suchthat a user can grip and remove the catheter 16 from the housing 12 foruse.

The external profile of the housing 12 can be any required for aestheticor functional purposes and, in the example shown, is generallycylindrical, tapering towards the first end to aid insertion into astorage receptacle or pocket, for example, and tapering towards thesecond end along the length of the cap 20.

The cap 20 comprises an open-ended generally cylindrical enclosurehaving a circumferential external wall which extends coaxially along thelongitudinal axis 22, and a radially extending, axially facing end wallwhich provides a closed end at the terminal end of the cap 20 andexternal housing 12. The cap 20 mates with the distal end of the mainbody 18, such that the main body 18 is received within an open end ofthe cap 20. However, it will be appreciated that the cap 20 could bereceived within an open end of the main body in some embodiments.

A hermetic seal may be provided between the cap 20 and main body 18 topreserve the sterility of the internal volume of the external housing12, prior to use. The hermetic seal of the embodiment describedcomprises one or more (in this case two) internal seals 66 and 68 asshown in FIGS. 3 and 5 and described further below.Additionally/alternatively a hermetic seal may be provided by a tamperproof connection or strip between the main body 18 and cap 20.

The external housing 12 may be used to transport the catheter 16 readyfor use and also to dispose of the catheter following use. In order toprevent the cap 20 being misplaced or separated from the main body 18whilst the catheter 16 is being used, and to avoid having an additionalitem to store in an environment which may not be conducive to hygienicstorage (such as a public lavatory) the cap 20 may be temporarilymounted to the main body 18. Thus, the cap 20 may be removed from theopen end of the main body 18 to expose the catheter 16 for removal anduse, and mounted on the closed end of the main body 18. Once thecatheter 16 has been used, it may be placed back within the main body 18and the cap 20 re-connected with the open end of the main body 18 toenclose the used catheter 16 therein for disposal.

This process can be seen in FIGS. 2 a to 2 c in which FIG. 2 a shows acatheter assembly 10 in which cap 20 is detachably attached prior touse, FIG. 2 b shows the cap 20 being removed from the main body 18 andmoved to the opposing end (as indicated by the arrows), and FIG. 2 cshows the cap 20 attached to the opposing end of the main body 18. Thecatheter 16 is not shown but it will be appreciated that it would beexposed at the uppermost end of the main body 18 as shown, when present.

To enable the temporary mounting of the cap 20 onto the closed end ofthe main body 18, the external surface of the closed end of the mainbody 18 and the inner surface of the cap 20 may comprise correspondingmating surfaces. These are indicated by reference 21 for the main body18 in FIG. 2 a and reference numeral 21′ in FIG. 9 c for the cap 20. Themating surfaces 21, 21′ may be configured to provide an interference fitin which the frictional engagement between the cap 20 and closed end ofthe main body 18 is sufficient to temporarily retain the cap 20. Theinterference fit may be achieved by providing a suitably shaped, and inthis embodiment suitably large contacting surface area between the innersurface of the cap 20 and outer surface of the main body 18. As such, anaxial portion of the outer surface of the main body 18 may have aprofile which corresponds to the inner surface of the cap 20. In theexample shown in FIGS. 2 a-2 c , the profile may be a uniform taper inwhich the angle of the taper along the mating surface is constant, butother profiles are possible.

The cap 20 and/or main body 18 will generally be substantially rigid soas to provide protection for the catheter 16 during transportation andto preserve integrity of the enclosed volume and maintain sterility.However, it will be appreciated that the cap 20 and/or main body 18 maybe sufficiently resilient to allow a small amount of deformation toassist with the interference fit between the cap 20 and main body 18.

In addition, or alternatively, to the inner surface of the cap 20 andthe outer surface of the main body 18 having corresponding profiles,either or both of the cap 20 and main body 18 may comprise matingsurfaces 21, 21′ comprising one or more formations which provide orenhance the interference fit and/or attachment of the cap 20 to the mainbody 18. For example, the cap 20 may be fitted to the closed end of themain body 18 using radial projections such as the ribs 286 b describedin relation to the embodiment of FIG. 15 below, using a click-fitengagement in which the cap 20 resiliently engages with one or moreinterlocking features such as a circumferentially extending rib or anumber of circumferentially distributed pips. Providing a click-fitengagement may help provide users with feedback that the cap 20 has beensecurely attached. Alternatively or additionally, the cap 20 and/or mainbody 18 may comprise one or more inserts, coatings (such as overmouldingwith a softer material), liners, screw threads or other features whichenhance one or more of the resilience, contacting surface area,coefficient of friction or engagement between the cap 20 and min body18.

The main body 18 and cap 20 may be made from thermoplastics, for examplepolypropylene. Other polymers such as polycarbonate, polyethylene, ornylon could be used. Equally an overmoulded design where a softermaterial is utilised on the inside of the cap or a portion of theoutside of the body may be used to aid with retention of the cap ontothe body

The cap 20 may be removed from the main body 18 in an axial directionprior to being inverted and located on the closed end of the main body18 in the same axial direction. The cap 20 may be pulled linearly offthe main body 18, or may be rotated or twisted off, for example, wherethe cap 20 is attached via a screw thread for example. An example of ascrew thread 62 b and 62 a can be seen in FIGS. 9 a and 9 c.

Part or all of the internal surface of the cap 20 may provide the matingsurfaces 21′. The embodiment of FIG. 9 c includes three portions whichprovide separate functions. The first portion is the mating surface 21′portion located distal-most and extending from the closed end towardsopen proximal end, ending partway along the internal length of the cap20. A second portion includes a screw thread 62 a for engaging with aninternal housing 14 of the catheter assembly 10, and the third portionprovides anti-rotation features 60 b, which are described further below.It will be appreciated that other configurations of cap 20 are possible,and the provision and respective location of the various portions maydiffer in other embodiments.

As noted above, the profile of the external housing 12 may belongitudinally tapered. The transverse cross-sectional profile of theexternal surface of the cap 20 may be any desired. The transversecross-sectional profile may be round, for example, circular or oval. Insome embodiments, the transverse profile may be polygonal such astriangular or square. FIG. 9 b shows an embodiment in which the externalsurface 20′ of the cap 20 is a rounded square to aid user's grip forrotating the cap 20 during actuation and/or removal steps.

With reference to FIGS. 1 a , 3 and 4, the main body 18 may provide anenclosure which defines a reservoir for a wetting fluid (not shown). Thereservoir is formed between the main body 18 and the internal housing14. Thus, the internal housing 14 may be provided within the externalhousing 12 in a spaced relation so as to define a cavil 28 therebetween.The cavity 28 may be referred to as a wetting agent storage chamber 28,or simply storage chamber 28 herein. The storage chamber 28 may comprisea first chamber wall provided by the main body 18 and a movable insertprovided by the internal housing 14. The internal housing 14 maytherefore provide a second storage chamber wall.

The storage chamber 28 is sealed in a first configuration such that thewetting agent is retained therein, and open in a second configurationsuch that the wetting agent can flow out of the cavity 28 so as to be inflow communication with and, in some embodiments, directly contact anexternal surface of the catheter tube 32 of the catheter 16.

When in the open configuration, the internal volume of the storagechamber 28 may be fluid communication with a wetting chamber 30 in whichthe catheter is located such that the wetting agent can flow from thestorage chamber 28 to the wetting chamber 30 and catheter tube 32. Insome embodiments, the fluid communication between the storage chamber 28and wetting chamber 30, may be via one or more valves, inlet channels,or intermediate chambers, such as a priming chamber for example. Anexample of a priming chamber is described further below.

As shown in FIGS. 1 a , 3 and 4, the enclosed volume of the externalhousing 12 may be partitioned by the internal housing 14 which may bereferred to as a movable insert. The internal housing 14 may comprise atubular wall which is configured to define the wetting agent storagechamber 28 on a radially outer side thereof, and a wetting chamber 30 ona radially inner side thereof.

As shown best in FIG. 4 , the internal housing 14 may comprise anelongate thin-walled structure which extends longitudinally along theprincipal axis 22 of the catheter assembly 10. The internal housing 14comprises a first end which is distal to the insertion end of thecatheter 16 and a second, proximal end which is proximal with respectto, and may surround, the insertion end 24 of the catheter 16. It willbe appreciated that the length of the internal housing 14 and theposition of the respective distal and proximal ends of the internalhousing 14, as well as the separation from the external housing chamberwall, may be varied across embodiments and determined to provide arequired volume for the wetting agent storage chamber 28. Further designconsiderations may arise where the internal housing 14 is configured toact as a pump for pumping the wetting agent from the storage chamber 28and/or a priming chamber to the wetting chamber during a wettingprocedure.

The welting chamber 30 comprises an elongate cavity between an internalsurface of the internal housing 14 and an external surface of thecatheter tube 32 such that a wetting agent (not shown) can be providedto the wetting chamber 30 for wetting the exterior surface of thecatheter tube 32 prior to use. The wetting chamber 30 may be holly orpartially defined by an internal surface of the internal housing 14and/or an intermediate member such as a sheath 34 which is locatedwithin the internal housing 14 and which surrounds the catheter tube 32during a wetting procedure.

The storage chamber 28 may be an elongate annular cavity which encirclesthe longitudinal axis 22 and catheter tube 32 and extends axiallybetween a first distal end and a second proximal end. The cavity may besealed at the first and second ends using one or more seals 36, 38. Theseals may comprise seal elements 36 a, 38 a which may be located betweenor against corresponding sealing surfaces 36 b, 38 b. The sealingsurfaces 36 b and 38 b may be provided by corresponding parts of theinternal housing 14 and external housing 12. The seal elements 36 a, 38a may be elastomeric seals in the form of, for example, an O-ring,X-ring, or U-cup seal. The seal elements may extend radially between theinternal housing 14 and main body 18.

In order to open the storage chamber 28, the catheter assembly 10 mayincorporate one or more valves which may be opened so as to fluidlyconnect the storage chamber 28 and wetting chamber 30. The one or morevalves may be operated by moving the movable insert, e.g. the internalhousing 14. The movable insert may be moved by direct manipulation froma user's hand, or by actuating the cap 20. For example, rotating orpulling the cap 20 may cause the one or more valves to open so as tofluidly connect the storage chamber 28 and wetting chamber 30 such thatwetting agent can flow from the storage chamber 28 to the wettingchamber 30 and an external surface of the catheter tube 32. The valvemay be provided in part by the internal housing 14.

The internal housing 14 may be axially movable along the principal axis22 of the catheter assembly 10. The axial movement may induce an openingat one or more of the seals 36, 38 which seals the storage chamber 28such that the opposing seal elements 36 a, 38 a and sealing surfaces 36b, 38 b of the respective seals 36, 38 move from an aligned sealed (orclosed) position, to a misaligned non-sealed (or open) position. Thus,for example, partially withdrawing the internal housing 14 from the mainbody 18 may cause the respective opposing surfaces' seal 36 to moveaxially in relation to one another and increase the separation of theinternal housing 14 and external housing 12 across the seal 36 whichprovides an opening. As such, one or more of the seals 36, 38 may act asthe aforementioned valve(s).

The seal 36 which is configured to act as a valve in this describedembodiment may be located proximally such that wetting agent in thestorage chamber 28 can flow from the proximal end of the storage chamber28 into the closed end of the main body 18 of the housing 12. This maybe referred to as a priming chamber. From there, the fluid is providedin flow communication with exterior of the catheter tube 32 eitherdirectly, or via one more inlets to the wetting chamber 30.

Also shown in FIGS. 3 and 4 is an optional insertion guide 25. Theinsertion guide 25 is a short elongate annular cuff which resides arounda proximal end of the catheter tube 32. The catheter tube 32 is slidablyreceived within the insertion guide 25 such that the insertion guide 25can move distally when the catheter tube 32 is being inserted. This isdescribed in more detail below.

As noted above, the storage chamber 28 is sealed by a proximal seal 36and a distal seal 38 to provide an elongate annular cavity in which thewetting fluid can be stored away from the catheter 16. The seals 36, 38of this described embodiment comprise elastomeric seals in the form ofO-rings which are located between opposing sealing surfaces. It will beappreciated that the seals 36, 38 may be alternative annular seals, forexample X-rings or U-cup seals. The sealing surfaces are provided bycorresponding and radially opposing portions of the internal housing 14and the external housing 12, it will be appreciated that, moregenerally, the catheter assembly 10 and storage chamber 28 in particularmay be provided with more than one distal seal 38 or proximal seal 36 toprovide the necessary sealing function.

One of the sealing surfaces may form part of a seal housing 36 d, 38 dwhich retains the seal element 36 a, 38 a and prevents axial movement ofthe seal element 36 a, 38 a. In some embodiments, the seal housing 36 d,38 d, may be provided by overmoulding the seal 36, 38 such that it ismoulded within a wall portion of the internal 14 or external housing 12.In the example shown, the seal housings 36 d, 38 d are provided by awall of the internal housing 14. Hence, the seal housing 36 d, 38 drestrains the axial ends of the seal elements 36 a, 38 a such that axialmovement of the internal housing 14 relative to the external housing 12allows the seal 36, 38 to slide with the internal housing 14 along theopposing sealing surface of the external housing 12. It will beappreciated that the seal housing(s) 36 d, 38 d may be provided by theexternal housing 12 in some embodiments.

As noted above, the axial movement of the seal 36 may expose or provideone or more outlets for allowing fluid communication between the storagechamber 28 and wetting chamber 30. Additionally, one or more seals mayopen one or more vents. The vents may act as air inlets configured toallow gas to enter the storage chamber 28 to replace the wetting agentas it exits the storage chamber 28. The vents may be internal so as toopen the storage chamber 28 to another internal cavity, or external soas to draw air in directly from the exterior of the assembly 10.

As shown in the embodiment of FIG. 4 , the proximal seal 36 may belocated adjacent a divergent portion 36 c in the storage chamber 28. Thedivergent portion corresponds to an increased separation between theexternal housing 12 and the internal housing 14, which may be providedby a step or taper in the profile of the respective surface of theinternal housing 14 and external housing 12. Hence, a seal 36 of thestorage chamber 28 may be located at a local restriction between theopposing walls of the storage chamber 28.

The divergent portion provides a space into which the seal 36 can bemoved when the storage chamber 28 is opened. Hence, when the internalhousing 14 shown in FIG. 4 is moved distally (so as to rise in the imageas shown), the seal 36 moves into the wider chamber portion, therebyopening a flow path from the storage chamber 28 into the proximal end ofthe main body 18. As such, the seal 36 operates as a valve and theinsertion end 24 of the catheter 16 may be submerged in wetting agentwhich has flowed from the storage chamber 28. As can be seen in FIG. 4 ,although both the internal housing wall and external housing wallcomprise steps/tapered portions which contribute to the divergence ofthe storage chamber 28, it is the wall which comprises the sealingsurface 36 b against which the seal element 36 a urges and moves againstthat provides the separation.

The distal seal 38 of the storage chamber 28 is axially spaced from theproximal seal 36 along the internal housing 14 and provided in a fixedlocation relative to the proximal seal 36. The distal seal 38 mayinclude a seal housing 38 d similar to the one provided for the proximalseal 36 such that axial movement of the internal housing 14 results atranslation of the seal element 38 a along the length of the externalhousing 12. The distal seal 38 in the embodiment of FIG. 4 differs fromthe proximal seal 36 in that the seal surfaces are substantiallyuniformly spaced and the seal surface 38 b which opposes the sealhousing 38 d and the active sealing surface of the seal element 38 aremains in contact with the seal element 38 a upon displacement of theinternal housing 14. As such, the distal seal 36 may remain in-tact asthe internal housing 14 is displaced and the proximate seal valveopened. As noted above, the axial movement of the proximal seal 38 mayresult in one or more vents being exposed and/or opened.

The internal housing 14 may be configured to provide pump for pumpingthe wetting agent into the wetting chamber 30. As such, the distal seal38 may be configured to maintain a higher pressure than proximal seal 36which is configured to maintain the integrity of the storage chamber 28when the assembly is stored and transported prior to use. As can be seenin FIG. 4 , the distal seal element 38 a may be larger than the proximalseal element 36 a.

As can be seen from FIG. 5 , the distal seal 38 of the storage chamber28 may be axially spaced from the open distal end of the main body 18.The extent of the distance may correspond to or be greater than thethrow (axial movement) of the internal housing 14 when undergoing awetting or priming operation. Hence, following a full movement of theinternal housing 14, the distal seal 38 may remain in contact with thewall of the external housing 12.

FIG. 7 shows an exploded view of an embodiment of the internal housing14 which comprises first 14 a and second 14 b parts joined together by ascrew threads 14 c. It will be appreciated that the specificconstruction of internal housing 14 may vary and it may, in someembodiments, be provided by a unitary structure or parts which arejoined using alternative methods, such as a push fit or bayonetconstruction.

As can be seen from FIG. 7 , one or more vents 40 may be provided in thesidewall of the internal housing 14. The one or more vents 40 mayprovide an outlet for the wetting chamber 30 such that air displacedfrom the wetting chamber 30 when wetting agent flows up or into thewetting chamber 30 can escape.

In some embodiments, the opening, of the storage chamber 28 may besufficient to wet the catheter, in which case, once the wetting chamber28 has been opened, it may be sufficient to withdraw the catheter 16 foruse (optionally inverting the assembly between opening the chamber andwithdrawing the catheter, in order to ensure adequate distribution ofwetting agent). In some embodiments, the wetting procedure for wettingthe catheter 16 may include a pumping or plunging action in whichwetting agent is pneumatically and/or hydraulically driven from thestorage chamber 28 into and along the wetting chamber 30.

In the embodiment shown in FIG. 1 , the pumping action may be providedby the axial movement of the internal housing 14 within the externalhousing 12. The internal housing 12, acting as a movable insert, may beconfigured to move axially to reduce the volume of the storage chamber28 thereby pumping/driving a flow of the wetting agent into the proximalend and the wetting chamber 30 so as to wet the catheter.

FIGS. 6 a to 6 c show a wetting operation of the catheter assembly 10 inwhich the internal housing 14 is moved distally and axially along thelongitudinal axis 22 from a first position to a second positionresulting in an opening of the storage chamber 28 and subsequent drivingof the wetting agent distally along the catheter tube 32. FIGS. 6 a to 6c show the actuation of the assembly with the cap 20 place, however, itwill be appreciated that this may not be the case in some embodimentsand the cap 20 may be fully removed. Further, the catheter assembly 10is shown as being horizontal, but the assembly may be operated in avertical orientation.

The wetting operation involves three primary phases. The first phase,shown in FIG. 6 a is a closed or sealed configuration/position in whichthe cap 20 is retained on the main body 18 of the housing 12 for storageand transportation purposes and the storage chamber 28 is sealed andincludes the wetting agent. In FIG. 6 b , the cap 20 is released fromthe main body 18 and the internal housing 14 moved axially and distallyvia the cap 20 such that the proximal seal 36 element moves away fromthe opposing seal surface provided by the main body 18 and a flow path42 opens to allow wetting agent 44 held in the storage chamber 28 to bemoved into the proximal end of the main body 18. This may be referred toas a priming phase or charging phase in which the wetting chamber 30, oran associated priming ante-chamber 46 is primed with the wetting agentready to be driven along the catheter tube 32. FIG. 6 b may be referredto as a priming configuration or priming position.

When the movable insert i.e. the internal housing, is in the primedposition, it is to be noted that the distal seal 38 maintains contactwith the inner wall of the main body 18 such that the leakage of wettingagent from the storage chamber 28 to the exterior of the catheterassembly 10 is prevented. However, one or more vents may be provided atthe distal end of the storage chamber 28, configured to allow gaseouscommunication between the storage chamber 28 and remainder of thecatheter assembly 10, when the internal housing is in the primedposition, one or more channels arranged between the storage chamber 28and the vents are opened which allows gas (i.e. air) to enter thestorage chamber to displace the wetting agent. Typically the assemblywill be held vertically, or at least with the closed end of the mainbody lower than the cap, such that gravity assists in allowing wettingagent to move into the closed end of the main body and the primingchamber. Optional ribs 64 discussed below also assist in allowingwetting agent to move from the storage chamber 28 to the primingchamber.

Once the wetting agent 44 has moved into the closed end of the main body18 and the priming chamber, the internal housing 14 can be re-insertedinto the main body 18 such that the wetting agent is forced up fluidpath 48 via an inlet to the wetting chamber 30 between the internalhousing 14 and catheter tube 32. Air displaced from the wetting chamber30 can exit from a suitable outlet which exhausts the displaced airoutside of the catheter assembly. FIGS. 6 c and 7 provide examples ofsuitable outlets in the form of openings 40 which are provided in theinternal housing wall and located between the distal end of the internalhousing 14 and distal end of the main body 28 so as to be exposedexternally. There are two diametrically opposed openings 40 in theembodiment shown, however, there may be fewer or greater than twoopenings 40. It will be appreciated that the size, shape and positionmay also differ. The openings 40 shown in the embodiment are oval havinga major axis extending circumferentially to allow a larger aperture fora reduced axial length.

The inlet to the wetting chamber 30 from the storage chamber 28/primingchamber 46 may be provided via the separation between the internalhousing 14 and catheter tube 32. In the embodiment shown in FIGS. 6 a to6 c , there is a sheath 34 surrounding the catheter tube 32 which mayform and at least partially define the wetting chamber 30, or may beprovided within the wetting chamber. In this case, the inlet to thewetting chamber may be provided between the catheter tube 32 and sheath34. Additionally, or alternatively, where an insertion guide 25 isincluded, the inlet may be determined by the separation between theinsertion guide 25 and catheter tube 32. In a further alternative, forexample with no sheath 34, the wetting chamber may be at least partiallyformed and defined by the inner surface of the internal housing 14. Theinlet may be defined by the separation between the bottom end of theinternal housing 14 and the catheter tube 32.

In some embodiments, the internal housing 14 may be reciprocated uponrotation of the actuator and thus moved back and forth several times.However, it will typically be sufficient to undertake a singledistal-proximal cycle to create a sufficient wetting of the cathetertube 32, thereby using the internal housing as a plunger.

As noted above, the plunging action of the internal housing 14 may beachieved by hand such that a user directly manipulates the internalhousing 14 distally and proximally along a linear axial path by pullingand pushing on the internal housing 14 whilst restraining the externalhousing 12. However, in some embodiments it may be preferable to drivethe movement of the internal housing 14 with an actuator.

The actuator, which may be referred to as a priming mechanism, may beany device which can cause the required axial movement of the internalhousing 14. The internal housing 14 may be configured to move axiallywhen rotated. In some embodiments, the actuator may comprise a cam-driveor crank in which rotational movement of the internal housing 14 is usedto drive the linear, axial motion of the internal housing 14 relative tothe main body 18. The rotational movement of the internal housing 14 maybe provided by a rotatable actuator in the form of a rotating cap 20,for example.

In some embodiments, the rotation of the cap 20 may be used to drive thelinear movement of the internal housing 14 and also to remove the cap 20from the main body 18. Thus, the rotation of the cap 20 may comprise afirst stage and a second stage. The first stage may correspond to thedriving of the internal housing 14 to open the storage chamber 28 and topump the wetting fluid around the catheter tube 32. The second stage maycorrespond to the releasing of the cap 20 from the main body 18 toexpose the catheter 16 for use.

The simultaneous rotational and axial movement of the internal housingmay be provided by one or more drive surfaces which are driven by acorresponding driving element. For example, the chamber wall provided bythe external housing or the internal housing may comprise one or moreaxially and circumferentially extending drive surface. The other of thechamber wall and movable insert may comprise a driving element whichengages with the drive surface to provide the axial movement of themovable insert upon relative rotation of the movable insert and chamberwall. The drive surface may comprise a first axially facing surfaceprovided by a radially projecting flange, rib, thread, track or rail.The driving element may comprise a second axially facing surface of aradially extending flange, rib, thread, track, rail or pin. The drivesurface and driving element may be referred to as a cam drive.

An embodiment of an actuator/priming mechanism having a drive surfaceand driving element will now be described in connection with FIGS. 7, 8a and 8 b. FIG. 7 shows a perspective exploded view of the internalhousing 14 which is described in part above. FIG. 8 a shows a side viewof a drive surface in the form of a plunger track portion of theinternal housing, and FIG. 8 b shows a schematic flattened front view ofthe plunger track 50 demonstrating a general shape a plunger track mayhave.

FIG. 7 shows a perspective view of the internal housing 14 in whichthere is provided an elongate thin-walled enclosure having respectiveseal housings 36 d and 38 d of a proximal seal 36 and distal seal 38 ofthe storage chamber 28 provided at opposing ends of the housing 14. Theexternal surface of the internal housing 14 comprises a drive surface inthe form of a track 50, which may be referred to as a plunger track,which engages with a corresponding driving element 52 (FIG. 8 a )appended to the external housing 12 (not shown). As shown, the plungertrack 50 may include a channel which receives the driving element 52 inthe form of a projection, e.g. a pin, which extends from an internalsurface of the external housing 12, or an intermediate member. Thechannel may be provided by a pair of axially separated guide rails inthe form of radially projecting walls 50 a, 50 b which extend from theexterior surface of the internal housing 14. The walls 50 a, 50 b may beparallel and join to form a closed track. However, in some embodiments,the track 50 may comprise partial walls in accordance with the directionof actuation required. That is, where the internal housing is urgeddistally, only the distal wall may be required to provide the necessarydrive surface, and vice versa.

It will be appreciated that, in some embodiments, the track 50 may beprovided on the interior surface of the external housing 12 andcorrespondingly the driving element 52 may be appended from the exteriorof the internal housing 14. It will also be appreciated that the plungertrack 50 and driving element 52 may comprise any suitable features forallowing the necessary driving engagement which translates therotational movement of the internal housing 14 into an axial movement.Thus, the track 50 and driving element 52 may comprise any combinationof a channels, grooves, ridges, protuberances, recesses, notches,bearings and gears, amongst others to provide the drive surface anddriving element.

The track 50 is provided proximally of the distal seal 38 such that itis located within the storage chamber 28. Providing the plunger track 50within the storage chamber 28 is optional and it may, in someembodiments be provided either distally or proximally of the distal 38and proximal 36 seals. However, providing the plunger track within thestorage chamber 28 may allow the overall length of the assembly 10 to beshorter and may provide a convenient point to fill the storage chamber28 with wetting agent, as discussed further below.

In some embodiments, the catheter assembly 10 may comprise a fillingaperture in the external housing such that wetting agent can beintroduced to the storage chamber 28 once the catheter assembly 10 hasbeen assembled. Thus, the aperture may be provided in flow communicationwith the storage chamber 28. Returning to FIG. 4 , there is shown anaperture 52 a which extends through the wall of the external housing 12,e.g. the main body 18, so as to provide access to the storage chamberexternally to the catheter assembly 10. The aperture 52 a may beconfigured to receive any suitable nozzle or attachment which isconnected to a source of wetting agent and may be referred to as a port.It will be appreciated though that the aperture 52 a may be aconventional round through-hole.

The positioning of the filling aperture 52 a in the described embodimentis such that it overlays the track 50, such that, following a fillingprocedure, the driving pin 52 can be inserted (and optionally welded inplace) to plug the filling aperture 52 a whilst extending into the track50 so as to fulfil the function of a driving element 50. It will beappreciated that the filling aperture may simply be plugged in otherembodiments and the plug may not provide a driving element 52 for theactuator for moving the movable insert.

As shown in FIG. 4 , although the internal housing 14 is generallyspaced from the external housing 12, the internal housing 12 may besnugly received within the external housing 12 such that there isminimal clearance between the outer edge of the track 50 and/or ribs andthe internal surface of the external housing 12. Providing a minimalclearance allows the track 50 and/or ribs 64 to keep the internalhousing concentric to the external housing when being moved.

To allow the wetting agent to flow from the aperture 52 a into thestorage chamber 28, the proximal rail of the track 50 may comprise adiscontinuity, e.g. an aperture 52 b, as can be seen schematically inFIG. 7 . There may be a plurality of discontinuities so as to provide a‘hyphenated’ guide rail. It will be appreciated that any aperture ordiscontinuity will typically be provided on a non-drive surface whichdoes not require contact with the driving element 52 to actuate theaxial movement of the internal housing 14. In some embodiments, theremay be no drive surface on the proximal side of the aperture,particularly where the reactive force for axially translating themovable insert is required on the distal side of the driving element 52.

As best seen in the schematic view of FIG. 8 b , the plunger track 50 iselongate and extends from a first endpoint 54 which corresponds to theclosed configuration or position, to a mid-point 56 which corresponds tothe primed configuration or position, to a second endpoint 58 whichcorresponds to the post-plunged wetted configuration or position. Thetrack 50 may be generally cosine or U-shaped extending from the firstend 54 at a distal-most location to the second point 56 at aproximal-most location to the third point 58 at the distal-most locationwhich is angularly (circumferentially) spaced from the first point.

The separation between the respective adjacent points 54, 56, 58 providethe axial movement of the internal housing 14 as the internal housing 14is rotated. Thus, the section 55 between the first end point 54 andmid-point 56 define, at least in part, the priming movement of theinternal housing 14 in which the proximal seal 36 is opened. The endsection 59 between the mid-point or primed position 56 and second endpoint or post-plunged wetted position 58 corresponds to the pumpingmovement which the internal housing 14 is reinserted to drive thewetting agent from the priming chamber to the wetting chamber 30. Theintermediate section 57 corresponds to the primed position in which theinternal housing 14 extends out of the external housing 12 with theproximal seal open such that the wetting agent can flow into the primingchamber 56.

The track 50 may be continually curved or comprise one or more straightportions. For example, as can be seen in FIG. 8 b , the track 50comprises straight portions for the first 55 and final sections 59 whichrepresent the majority of the transitions between the distal-most andproximal-most positions of the internal housing 14. The lower portion ofthe track 50 is broadly flat with little to no axial displacement and soprovides a dwell period in which the internal housing 14 is rotated inthe open configuration to provide sufficient time for the wetting fluidto drain from the storage chamber 28 into the priming chamber 46provided at the proximal end of the main body 18.

It will be appreciated that the term “straight portion” used aboverefers to the axial trajectory of the track 50 as revealed by thefront-on view taken when the track 50 is flattened out, as provided inFIG. 8 b . The track 50 itself will continuously curve due to itextending circumferentially around the longitudinal axis 22.

The terminal ends 54, 58 of the track 50 may be provided with a changein trajectory such that the speed of the axial movement along thelongitudinal axis 22 may be reduced when the movement is commencing andterminating to provide an improved tactile experience for the user. Thatis, leading into the actuation and out of the actuation with a reducedacceleration and deceleration may provide a less abrupt start and finishto the actuation and provide an improved user experience. Moreover, alower axial movement may offer a mechanical advantage as movementcommences, against the resistance to axial movement caused by the seals.

In use, the internal housing 14 is rotated such that the driving element52 travels along the track 50. As the driving element 52 is held in astationary relation to the external housing 12, rotation of the internalhousing 14 results in a linear movement along the longitudinal axis 22of the catheter assembly 10. The initial phase of the movement in theproximally extending portion of track 50 results in a distal movement ofthe internal housing 14 so as to open the proximal seal 36, as describedabove. From there, the driving element 52 enters the rotation portion 57in which the wetting agent 44 drains out of the storage chamber 28 witha reduced amount of axial movement, which is then followed by the thirdportion 57 of the track which drives the internal housing distally andtowards the priming chamber.

The arrangement of the track 50 is such that rotating the internalhousing 14 in a single direction for a predetermined angular extent,i.e. a given rotation of the cap 20, causes a full linear cycle ofmovement. The predetermined angular extent may be any which isconsidered appropriate for the cap 20 and user experience.

The terminal end of the track 58 is provided with a closed end such thatfurther rotation of the internal housing is not possible once thedriving element 52 contacts the closed end. As such, the actuator may beprovided with a mechanical stop or rotational limiter which the rotationof the internal housing. This can provide mechanical feedback to theuser to indicate that the priming and/or wetting phase of the catheterhas been achieved and the catheter can be removed. Following themechanical feedback, the cap 50 can be removed and catheter 16 withdrawnfor use.

It will be appreciated that the extent of the rotation will determinethe amount of force required to move the internal housing. Thus, a shortangular extent, for example 90 degrees, will result in a faster movementof the internal housing and will require a greater force when comparedwith a longer rotation of, for example, 270 degrees. The range ofangular movement may be between 90 degrees and 360 degrees.

In embodiments where the rotation of the internal housing 14 relative tothe main body 18 is achieved via the cap 20, the cap 20 and/or internalhousing may comprise one or more interlocks to rotationally engage thecap 20 and internal housing 14. There may be a plurality of interlockswhich may be distributed circumferentially about the cap 20 on theinternal surface thereof.

Referring to FIGS. 9 a to 9 c , it can be seen that an interlock may beprovided by respective interengaging projections 60 a on an externalsurface of the internal housing 14 which are received withincorresponding recesses 60 b in the internal surface of the cap 20. Ascan be seen, there may be a plurality of interlocks 60 a,b evenlydistributed about the periphery of the cap 20 and internal housing 14 toprovide multiple points of engagement. The embodiment shows fourinterlocks, however, there may be greater than or fewer than this. Therecesses 60 b are shown as being provided in the thicker section of thecap 20 wall so as to maintain a minimal thickness at the proximal edgeand provide the necessary the hoop strength. However, this is not alimitation and the recesses 60 b may be provided in different or othercircumferential locations.

The interlocks 60 a,b may comprise a torque activated release such that,upon reaching a predetermined threshold of rotating torque on the cap,the interlocks release allowing the cap 20 to rotate relative to theinternal housing 14. Thus, once the travel of the driving element 52reaches the end of the drive surface and engages the rotational limiter,an increased torque and continued rotation of the cap 20 overcomes theinterlocks and allows the cap 20 to rotate relative to the internalhousing 14. Once released, the further rotation of the cap 20 may allowthe cap 20 to be removed.

To provide the torque activated release, the interlocks may compriseshapes which are configured to disengage beyond a given torque. Theshape of the projections 60 a and recesses 60 b may correspond to oneanother such that the surfaces of the recesses 60 b are provided inintimate contact with the projections 60 a. When viewed in plan, it canbe seen that the contacting surfaces are inclined relative to thetangent at the respective locations such that the projections aretriangular. Providing tangentially inclined surfaces contacting surfacesin this way provides a convenient way to control the torque thresholdthe interlocks can withstand before releasing, allowing the interlocksto release when the driving element 52 reaches the terminal end 58 ofthe plunger track 50.

The recesses 60 b and projections 60 a may be configured to preventrotational separation only, with axial engagement between the internalhousing 14 and cap 20 being provided by other features. Hence, as shownin FIG. 9 c , the recesses 60 b may be provided in the proximal edge ofthe cap 20 adjacent to the open end. This provides the recesses 60 bwith an open end along the axial direction.

To prevent the cap 20 being pulled axially off the internal housing 14in a distal direction, the cap 20 and/or internal housing 14 maycomprise an axial retention feature which retains the relative axialposition with the internal housing 14 whilst the cap 20 is beingrotated. In the described embodiment, the axial retention feature isprovided by a screw thread 62 a which engages with a screw thread 62 bon an external surface of the internal housing 14. The screw thread maybe used to remove the cap 20 from the internal housing 14 once theplunging action is complete and the torque threshold has been overcome.Removing the cap 20 from the screw thread may expose the catheter for auser to handle.

The screw threads 62 a,b may comprise partial turn or full turn threads.The partial turn threads may comprise, for example, a quarter turnthread in which the cap 20 is removed following a quarter turn of thecap 20 following the rotational disengagement from the internal housing14.

As noted above, the rotation of the cap 20 may comprise a plurality ofstages. The rotation of the cap 20 may comprise a priming step and aremoval step. The priming step and removal step may be sequential and beachieved by rotating the cap 20 in the same rotational direction. Thesum of the first and second steps may correspond to the number or turnsrequired to remove the wet the catheter and remove the cap 20. Forexample, a full 360 degree rotation of the cap 20 may result in thewetting and removal of the cap 20. The wetting phase may comprise a 270degrees, or three-quarter turn and the removal of the cap 20 maycomprise a further quarter turn. Other combinations of turns and turnsteps may be possible.

The driving element may comprise a plug which is received within afilling orifice of the storage chamber 28. Thus, the main body 18 maycomprise at least one aperture extending through an external wallthereof, the aperture providing access to the internal volume of thestorage chamber 28 such that the wetting fluid may be received via theaperture. The aperture may be configured to receive the drivingelement/plug 52 following the filling procedure. Thus, the aperture mayoppose the first end 54 of the track.

The internal volume of the catheter assembly may be sterilised followingassembly. In order to preserve the sterility of the internal volume thecatheter assembly may comprise a hermetic seal. The hermetic seal maycomprise an external surface of the catheter assembly or may compriseone or more seals located within the cap 20 and/or main body 18. Thehermetic seal may be broken by rotation of the cap relative to the mainbody. Returning to FIG. 5 , there are shown hermetic seals 66 and 68provided on either side of the joint between the main body 18 and cap20. The seals 66 and 68 may be similar to other seals described hereinand comprise elastomeric seal elements held within a seal housing.

The hermetic seals 66 and 68 may be broken when the cap 20 is removedfrom the main body 18. Thus, rotating the cap 20 to initiatetransitioning from the sealed configuration to the primed configurationmay break (i.e. open) the seal 66 or 68. In the case where the internalhousing 14 is moved distally with the rotation of the cap 20, the seal68 will open initially, thereby breaking the hermetic seal before thecap 20 is actually separated from the internal housing. However, thedistal seal 38 will prevent the wetting agent leaving the distal end ofthe storage chamber, thereby rendering the catheter assembly in a primedby leak-resistant configuration. This is advantageous as it allows thecatheter assembly 10 to be left temporarily once primed such that a usermight put the catheter aside for a short time once opened, for example,to adjust position and/or clothing (or even for longer, to answer thedoor, say, before returning to catheterisation) prior to removing thecatheter from the external housing.

Returning to FIG. 7 , it can be seen that the internal housing 14 may beprovided with optional ribs 64. The ribs 64 may be included to maintainthe separation of the internal housing 14 and external housing 12 whichdefines the storage chamber 28. Hence, when ribs 64 may assist inguiding the internal housing 14 when moved axially and rotationally. Theribs 64 may also aid with the pumping action of the internal housing 14when it is reinserted into the external housing 12. Thus, the ribs 64may act to drive the wetting agent proximally into the closed end and upthe wetting chamber 30.

The ribs 64 may extend circumferentially around the internal housing 14.The ribs 64 may be discontinuous in the circumferential direction suchthat a flow path may be maintained between adjacent ribs 64. As can beseen, the ribs 64 may be provided along the length of the internalhousing 14. In the embodiment shown there are three sets of ribs 64disposed at regular intervals along the length of the internal housing14. Each set of ribs 64 includes four separate circumferential sub-ribsprovide at common axial locations above a circumferential line with theribs having the same angular length. It will be appreciated that thespecific arrangement of the ribs may vary in other embodiments.

The sequential priming, wetting and cap removal rotation is shown inFIGS. 10 a to 10 f which show the major steps for removing a catheterfrom an embodiment catheter assembly.

FIG. 10 a shows the catheter assembly 10 in a closed, pre-activationconfiguration in which the hermetic seal is intact and the interiorcavity of the external housing 12 is sterile. FIG. 10 b shows a firststep in which the cap 20 is turned through an initial rotation phase.The initial rotation of the cap 20 rotates the internal housing 14 viathe rotational engagement provided by the interlocks 60 a and 60 b. Therotation of the internal housing 14 causes the drive surface provided bytrack 50 and driving element 52 to move the internal housing 14 in anaxially distal direction, together with the cap 20. As can be seen inFIG. 10 c , the distal movement of the internal housing 14 opens thehermetic seal 68 and the proximal seal element 36 a transitions of thedivergent portion so as to open a flow path for the wetting agent, asseen in FIG. 10 d . At this point, the wetting agent flows into thepriming chamber 44 at the proximal end of the main body 18 and thecatheter assembly is primed. A continued rotation of the cap 20, movesthe internal housing 14 back into the main body 18 at which point theribs 64 pump the wetting agent from the priming chamber 44 up thewetting chamber inlet provided between the internal housing andinsertion guide (if present) and the catheter tube 32. Once the drivingelement 52 reaches the end of the drive surface provided by track 50,further rotation is not possible without an increase of torque. Thus,the user is provided with some mechanical feedback that the catheter 16has been wetted. The above actions are carried out with a single useraction, i.e. the rotation of the cap 20 in a common direction using asubstantially constant torque.

Following this first rotational step of the cap 20, the cap 20 isfurther rotated releasing the torque activated release interlock therebyallowing the cap 20 to move relative to the internal housing 12 via thethreads 62 a,b. Following the removal of the cap 20, the catheter 16 maybe grasped by the external handling surfaces on the outlet end 26 of thecatheter 16 and withdrawn axially, ready for use. Where a sheath 34 hasbeen employed, this will be in a deployed position with the catheter 16located therein to preserve the sterility thereof during manipulation.

Referring to FIGS. 1 and 3 , the catheter 16 may be any suitablecatheter known in the art. As shown, the catheter 16 may comprise acatheter tube 32, and a funnel 26.

The catheter tube 32 may be an elongate thin-walled structure whichextends longitudinally along the principal axis 22 of the catheterassembly 10. The catheter tube 32 may be comprised of a flexiblematerial. A first end of the catheter tube 32 may be closed with ahemi-spherical cap, and form the insertion end 24 of the catheter 16,the hemispherical shape aiding with insertion.

Proximate to the insertion end 24 there may be provided one or moredrainage apertures 33, in this embodiment the drainage apertures 33 areoval in shape with the major axis being parallel with the principal axis22. It will be appreciated that the size and shape of the drainageapertures 33 may differ.

The exterior surface of the catheter tube 32 may be, as is known in theart, functionalised, such that when wetted by the wetting agent theco-efficient of friction of the catheter tube 32 is reduced. The outersurface of the catheter tube 32 may be comprised of, or coated in, afunctionalising material; for example the outer surface of the cathetertube 32 may have hydrophilic properties. The hydrophilic propertiesserve to reduce the coefficient of friction of the outer surface whenthe wetting agent is introduced.

The end of the catheter 16 distal to the insertion end 24 is providedwith a catheter outlet end 26. In this embodiment the catheter outletend 26 is provided as a funnel 26 and is a separate component to thecatheter tube, in other embodiments they may be integrally formed. Thefunnel is cylindrical in shape having a first open end and a second openend. The first open end is configured to receive the catheter tube 32 bythe end distal to the insertion end 24. The catheter 16 is configured toprovide fluid communication between the drainage apertures 33 and thecatheter outlet end 26.

Projecting radially from the exterior surface of the funnel 26 there maybe one or more projecting ribs. In the embodiment of FIG. 4 there areprovided two projecting ribs; the first rib 35 a is arranged proximateto the second end of the funnel and the second rib 35 b is arrangedbetween the first rib 35 a and the first end of the funnel. The secondrib 35 b is sized such that its external diameter corresponds to theinternal diameter of the distal end of the internal housing 14. Thefirst rib 35 a is sized such that its external diameter is greater thanthe internal diameter of the distal end of the internal housing 14 andless than the internal diameter of the open end of the cap 20. Thearrangement of the two projecting ribs 35 a,b may be provided tomaintain the position of the catheter 16 relative to the internalhousing 14; the second rib 35 b ensuring the catheter 16 and internalhousing 14 are arranged coaxially, and the first rib 35 a limiting theextent to which the catheter 16 can be inserted into the internalhousing 14 proximally along the principal axis 22.

A region of the exterior surface of the funnel between the second end ofthe funnel and the first rib 35 a may be textured to provide a grippingsurface for a user. Where the exterior surface of the funnel between thesecond end of the funnel and the first rib 35 a is used as a grippingsurface, the projecting ribs 35 fulfil an additional function, providingseparation between a user's fingers and the (wetted) catheter tube 32.

As noted above, FIGS. 1 and 3 also show an optional sheath 34. Thesheath is formed of a flexible material and is arranged surrounding thecatheter tube 32. The sheath is coupled at a first end to the funnelproximate to the first open end thereof, and at a second end to theinsertion guide 25. The insertion guide 25, or part thereof, iscomprised of an elastically deformable material.

In use, after completing the wetting cycle and removing the cap 20, auser withdraws the wetted catheter 16 from the catheter assembly 10.Holding the gripping surface of the funnel 26 and where present, theinsertion guide 25, the user directs the catheter tube 32 into a canal,vessel, passageway, body cavity, etc. for removal of fluid therefrom.

Where the sheath 34 and insertion guide 25 are present, the user gripsthe insertion guide 25 to guide the catheter tube 32. The user squeezesthe insertion guide 25, deforming it such that it engages with thecatheter tube 32, restricting axial motion of the catheter tube 32through the insertion guide 25 and inserts a first section of thecatheter tube 32 exposed from within the sheath 34 into the canal,vessel, passageway, body cavity etc. Once the first section of thecatheter tube 32 has been inserted, the user relaxed their grip on theinsertion guide 25, allowing it to return to its original shape, andslidably draws the insertion guide 25 along the catheter tube 16 awayfrom the insertion end 24, furling a portion of the sheath 34 andexposing a second section of the catheter tube 16. The process is thenrepeated, with the user squeezing the insertion guide 25 to restrict themotion of the insertion guide 25 with respect to the catheter tube 16and the second section of the catheter tube inserted. The process isrepeated until the catheter tube is inserted sufficiently into thecanal, vessel, passageway, body cavity etc.

FIG. 11 shows an axially exploded view of a catheter assembly 210according to the present invention. FIG. 12 shows an external view ofthe catheter assembly 210 in a sealed configuration. The catheterassembly 210 comprises an external housing 212, a wetting agent storagechamber 228 and a catheter 216. The external housing 212, wetting agentstorage chamber 228 and catheter 216 are concentrically arranged suchthat the catheter 216 is located within the storage chamber 228 which islocated within the external housing 212 in a radially nestedconfiguration.

The external housing 212 comprises a main body 218 in which at least aportion of the storage chamber 228 and catheter 216 are housed, and acap 220 which is detachable so as to be removed by a user prior to use.Removal of the cap 220 exposes the catheter 216 for withdrawal from theexternal housing 212 for use.

The main body 218 may further comprise a catheter tube section 219 and astorage chamber section 221. The catheter tube section 221 houses thecatheter tube 232 of the catheter 216. The storage chamber section 221houses the storage chamber 230. The catheter tube section 219 andstorage chamber section 221 may comprise separate components which areattached together to provide the main body portion 218, or may beprovided by parts of a unitary structure. It will be appreciated thatportions of the storage chamber section 219 may house portions of thecatheter tube 232 and catheter tube section 221 may house portions ofthe storage chamber 228. Typically, the catheter tube section 221 willprovide the terminal proximal end of the housing 212.

The external housing 212 provides an enclosed volume in which thecatheter 216 can be housed for storage and transportation prior to use.The main body 218 and cap 220 may provide a sterile cavity in which thecatheter 216 is located. The external housing 212 is generally elongatehaving a longitudinal axis 222 which can be taken to be the principalaxis of the catheter assembly 210 which is coaxial with the longitudinalaxis of the storage chamber 228 and catheter 216.

The enclosed volume provided by the external housing 212 is defined byan external wall of the housing 212 which extends from a first proximalend 213, which receives an insertion end 224 of the catheter 216, to asecond distal end 215 in which a catheter outlet end 226 is received. Inthe embodiment shown, the second end 215 is provided by the cap 220.Thus, the removal of the cap 220 exposes the outlet end 226 of thecatheter 216 such that a user can grip and remove the catheter 216 fromthe housing 212 for use.

The external profile of the housing 212 can be any required foraesthetic or functional purposes and may, incorporate similar externalfeatures to the external housing 12 described above. Hence, the externalhousing 212 may be generally cylindrical, tapering towards the first endto aid insertion into a storage receptacle or pocket, for example, andtapering towards the second end along the length of the cap 220.Additionally, the cap 220 may be temporarily stored on the opposing endof the external housing 212 as shown in FIGS. 2 a to 2 c.

A hermetic seal may be provided between the cap 220 and main body 218 topreserve the sterility of the internal volume of the external housing212, prior to use. The hermetic seal may comprise a sealing element,such as an O-ring seal 297 b provided between the main body 218 and cap220 as best seen in FIG. 13 , in which case the O-ring seal sits on acircumferential sealing surface on the outside of the main body 218,which, when the cap 220 is sealed faces a corresponding circumferentialsealing surface on the inside of the cap.

In an alternative, a hermetic seal may be provided by a tamper proofconnection or strip between the main body 218 and cap 220. An example ofa hermetic seal 297 a formed as a tamper proof strip is provided in FIG.12 . The seal 297 a comprises a portion of the external surface of theexternal housing 212. As such, the external housing 212 may comprise amain body 218, a cap 220 and a hermetic seal 297 a. The hermetic seal297 a 1 b may be configured such that rotating cap 220 breaks the seal297 a. Breaking the seal 297 a/b may be done during a priming step whichputs the catheter assembly into a primed configuration.

The storage chamber 228 provides a reservoir for the storage of awetting agent prior to the wetting of the catheter tube 232. The storagechamber 228 is provided at a distal end of the catheter tube 232 suchthat the catheter tube 232 may be drawn through wetting agent retainedwithin the storage chamber 228 when the catheter is being withdrawn fromthe housing 212. Alternatively or additionally, upon opening the storagechamber 228, the wetting agent may flow down the exterior surface ofcatheter tube 232 (which as in the previous embodiment may befunctionalised so as to be hydrophilic) towards the closed end of themain body 218

Referring to FIG. 13 the storage chamber 228 surrounds the catheter 216and comprises a chamber wall 231, 235 which seals against seal surfaces239, 241 provided on the catheter 216 and provides an annular enclosedvolume in which the wetting agent is stored prior to use. The storagechamber wall 231, 235 is sealed against the catheter 216 using first andsecond seals 233, 237 which are axially separated and may be provided atthe distal and proximal ends of the storage chamber 228. As the catheter216 seals the storage chamber 228, it may be considered to form part ofthe storage chamber 228.

The catheter 216 therefore comprises, a movable insert such that it canbe moved relative to the storage chamber wall 231. The catheter 216 maybe configured such that it is axially movable when rotated. The rotationof the catheter 216 may be achieved by via rotating the cap 220. Assuch, the cap 220 and catheter 216 may be rotatably engaged.

The chamber wall 231, 235 may comprise multiple components which arejoined together to provide a sealed external wall to provide theenclosed volume which is sealed against the catheter 216.

The storage chamber section 219 may be configured to prevent relativerotation of the storage chamber 228. Thus, when the catheter 216 isurged to rotate within the storage chamber 228, the storage chambersection 219 prevents the storage chamber 228 from rotating about thelongitudinal axis 222. As such, the catheter 216 which passes throughthe storage chamber 228 can be rotated relative to the housing 212 andstorage chamber 228 during a release and/or wetting procedure.

The storage chamber section 219 may also be configured to prevent axialmovement of the storage chamber 228 during a release and/or wettingprocedure. The axial retention of the storage chamber 228 may be limitedto be below a predetermined threshold such that when an axial pullingforce above the predetermined threshold is achieved, the storage chamber228 is released from the housing 212 and able to move axially.

As can be seen from FIG. 13 , the storage chamber 228 may be an elongatestructure which extends coaxially along the longitudinal axis 222 todefine an annular cavity in which the wetting agent may be stored. Theannular cavity is defined by a radially outer wall with axially facingend walls which extend between the radially outer wall and catheter 216.The end walls may extend from the ends of the radially outer wall in thenormal plane of the longitudinal axis 222, but this is not a limitationand other configurations are envisaged. The end walls may comprise orterminate at the radially inner edge in axially extending annularflanges at either or both ends of the storage chamber. An embodiment ofthese is described in further detail below.

As noted above, the movable insert is configured to move axially alongthe longitudinal axis 222 with respect to the chamber wall 231. Themovement of the catheter 216 may transition the catheter 216 between afirst position and a second position. In the first position the storagechamber 228 is sealed by the seal element 233 a located between thechamber wall 231 and the catheter 216. The seal element 233 a is alignedwith sealing surfaces 233 b in the first position. In the secondposition the sealing element 233 a is configured to be axiallymisaligned with at the sealing surface 233 b. In this way, the seal 233can be opened in the second position, or as described below, thecompression of the seal element 233 a can be reduced such that thestorage chamber 228 remains sealed, but the catheter 216 may bewithdrawn more readily to effect the welling of the catheter tube 232.Although the seal element 233 a and sealing surface 233 b are shown asbeing placed on the chamber wall 231 and catheter body 243 respectively,this may not be the case and they may by the other way round.

The first and second seals 233 and 237 are axially separated and sealagainst a portion of the catheter 216. At least one of the movableinsert, e.g. the a portion of the catheter 216, and the chamber wall 231may comprise a divergent portion over which the seal element 233 apasses when transitioning between the first sealed position and secondprimed position. The divergent portion is such that the distance betweenthe chamber wall 231 and movable insert at the axial location of theseal element 233 a is increased when in the second primed position. Thedistance may be a radial distance with respect to the longitudinal axis222. The divergent portion may comprise a widening of a cavity adjacentto the seal surface 233 a. The divergence may be provided by a step ortaper adjacent to the sealing surface.

FIGS. 14 a and 14 b show a side view of the catheter 216 with the first233 and second 237 seals shown in section. FIG. 14 a shows the positionof the catheter 216 in a sealed/storage configuration, FIG. 14 b showsthe catheter 216 in a primed configuration. The primed configuration isone in which the catheter 216 is configured to be removed from theexternal housing during a second stage of the catheter 216 deployment,(the first stage being the priming).

With reference to FIGS. 13, 14 a and 14 b, the first 233 and second 237seals may be provided by respective seal elements 233 a and 237 a whichare located against an opposing seal surface 233 b and 237 b on thecatheter 216. The sealing surfaces 233 b and 237 b may be considered tobe primary sealing surfaces.

In the described embodiment, the seal surfaces 233 b and 237 b areprovided by a catheter body 243. The body 243 thus constitutes themoveable insert and is provided between the outlet end 236 of thecatheter 216 and the catheter tube 232. As shown, the catheter body 243may have an increased radius compared to the catheter tube 232 and isprofiled to provide the seal surfaces 233 b and 237 b.

The catheter body 243 may extend to the distal end of the catheter 216and be an extension thereof. The distal end of the catheter body 243 mayprovide the outlet of the catheter 216 which may be shaped externallyand internally to provide the external handling surfaces and internalflow enhancing features. Hence, the exterior of the catheter body 243may include an external handling surface which includes a plurality ofgrooves which aid the handling of the catheter by a user's finger tips.The internal surface may also include a funnel which diverges in a flowdirection. These features of the catheter 216 have been described inconnection with FIGS. 1 and 3 and will not be described further here.

The first seal surface 233 b is provided at a proximal end of thecatheter body 243 and storage chamber 228 and provide a raised portionagainst which the seal element 233 a resides when in a sealedconfiguration. The raised portion includes a first diameter D233 whichis greater than a diameter d233 on an adjacent portion of the catheterbody 243 on proximal side and, optionally, distal side. As such, thesealing surface 233 b is separated by a step or chamber in the profileof the catheter body 243.

In the example shown, the seal surface 233 b and adjacent portion areshown as being cylindrical. Hence, the seal surface 233 b comprises acylindrical surface having a first radius with the adjacent proximalsurface being provided by a second radius which is smaller than thefirst radius. Thus, as shown by FIG. 14 b , relative axial movementbetween the catheter 216 and the seal element 233 a which is retained bythe storage chamber 228 moves off the seal surface 233 b over theproximally adjacent surface defined by diameter d233, there is either: aseparation between the seal element 233 a and adjacent surface or areduced contact which allows the storage chamber to be sealed but thecatheter more readily withdrawn. As shown in FIG. 14 b , the sealcontact is maintained with the compressive force, and thus axialretention, on the catheter body 243 and catheter 216 being reduced. Inthis regard, the proximal shaft of the catheter body 243 may provide asecondary proximal seal surface 233 c. Hence, in the sealedconfiguration the seal 233 may act to provide an increased sealingpressure which can help reduce the evaporation loss from the storagechamber 228.

The distal seal 237 comprises a distal seal element 237 a which issealably located against a seal surface 237 b provided by the catheterbody 243. In contrast to the proximal seal 233, the distal seal surface237 b is provided by a constant cross-section such that a constant seal237 is maintained when there is relative axial movement between thecatheter 216 and storage chamber 228.

As shown, the distal seal surface 237 b may be defined by radialupstands which locate the seal element 237 a with a defined axial rangeof the catheter body 243. The radial upstands may be provided as part ofa groove within a surface of the catheter body 237, one or more flanges,or an increase in the diameter of the catheter body 243. FIGS. 14 a and14 b show a distal sealing surface 237 b having a combination of aradial flange being provided on the righthand, proximal, side, anincrease in diameter being provided on the left hand, distal, side, withthe seat of the seal surface 237 b being provided as a groove in thesurface of the catheter body 243 shaft which extends between the first233 and second seals 237.

As can be seen in FIGS. 13 and 14 b, when the catheter 216 is moveddistally so as to be withdrawn from the housing 212 (as indicated by thearrow in the centre of the catheter body 243), the distal seal element237 a is retained by the radial upstand so as to be retained around thecatheter body 243. The proximal seal element 233 a is retained by thestorage chamber 228 as the catheter is withdrawn.

It will be appreciated that the storage chamber 228 may comprisefeatures to retain the seal elements 233 a and 237 a in place and urgethe seal elements 233 a and 237 a radially inwards to provide the seal.For example, the seals 237 a and 233 a may be retained by a seal housingand may be overmoulded. A specific embodiment pertaining the retentionof seal element 233 a is provided below in connection with FIG. 16 a.

The seal elements 233 a and 237 a may be different sizes. Morespecifically, the proximal seal 233 may comprise a larger seal element233 a to allow for the increased compression and increased contact areawith the sealing surface 233 b when in the first sealed configuration.

The seal elements 233 a and/or 237 a may comprise an elastomericmaterial. The seal elements 233 a and 237 b may be O-rings,alternatively they could be X-rings or U-cups, or other similar annularseal.

The catheter 216 is configured to move axially relative to the externalhousing 212 and storage chamber 228. This not only allows the catheter216 to be withdrawn from the external housing 212 for use, but alsoallows the catheter tube 232 to pass through the wetting agent housed inthe storage chamber 228. Thus, the catheter 216 has a sealed (orstorage) configuration and a primed configuration from which thecatheter 216 is withdrawn and wetted. The sealed configuration of thecatheter assembly 210 and catheter 216 is shown in FIGS. 2 and 14 arespectively. As described above, the primed configuration prior to thewithdrawal of the catheter 216 is shown in FIGS. 13 and 14 b.

The movement of the catheter 216 from the sealed configuration to theprimed configuration may be achieved by a user axially withdrawing thecatheter 216 in the distal direction. The withdrawal may be achieved bythe user gripping the outlet end 226 of the catheter either directly, orindirectly, for example, via the cap 220.

The axial withdrawal may be achieved using an actuator. The actuator maybe referred to as a priming mechanism. The priming mechanism compriseany device which can cause the required axial movement of the catheter216 in relation to the external housing 212 and storage chamber 228. Insome embodiments, the priming mechanism may comprise the catheter whichis configured to be rotatable such that the rotating induces the axialmovement. The priming mechanism may comprise a cam drive or crank inwhich a drive surface engages with a drive element such that relativerotation of the driving element or drive surface results in the axialmotion of the catheter 216 relative to the main body 218. The rotationalmovement may be provided by a rotatable actuator such as the cap 220which may be rotationally engaged with the catheter 216 as the movableinsert.

FIG. 15 shows an embodiment in which the catheter body 243 is providedwith a cam drive 281. The cam drive comprises a drive surface in theform of a ramp formation provided by an axially facing end wall surfaceof the storage chamber wall 231, and a driving element comprisingcircumferentially extending fins 282 which extend axially andcircumferentially so as to provide a helical projection which isfunctions as a screw thread/cam. The fins 282 engage with thecorresponding ramp formations 284 provided on the storage chamber 228such that rotating the catheter 216 causes the fins 282 to travel alongthe ramp formations 284 and urge the catheter 216 distally relative tothe storage chamber 228.

Urging the catheter 216 distally results in an axial sliding of thecatheter 216 relative to the storage chamber seals 233 and 237 and themovement of the proximal seal element 233 a and the associated sealsurface 233 b, as described above in relation to FIGS. 14 a and 14 b.

The rotation of the catheter 216 may be achieved by the user grippingand rotating the external handling surface of the catheter outlet end226, or via a rotation of the cap 220. Rotating the cap 220 may beachieved by providing a rotational engagement between the cap 220 andthe catheter body 243.

As can be seen in FIGS. 13 and 15 , the rotational engagement may beprovided via corresponding radial projections 286 a and 286 b on thecatheter body 243 and the interior of the cap 220. The projections maytake any suitable form and may comprise radially extending members inthe form of ribs, flanges, projections, pins, pedestals etc. as notedabove, the projections may serve a dual purpose, also assisting inretaining the cap 220 on the base of the main body 218 duringcatheterisation.

With reference to FIGS. 11 and 15 , the cap 220 is also shown ascomprising screw threads 288 a which engage with corresponding screwthreads 288 b provided on the exterior of the distal end of the mainbody 218 such that the cap 220 can be releasably attached to the mainbody 218.

As the catheter 216 rotationally engages with the cap 220, rotating thecap 220 for removal from the main body 218 via screw threads 288 a and288 b, results in the catheter 216 rotating and being withdrawn from thestorage chamber 228 via the cam drive 281. Thus, rotation of the cap 220with respect to the main body 218 results in a rotation of the catheter216. It will be appreciated from this, that the pitch of the cam-driveribs/ramp formations will be the same as the pitch of the screw threads288 a,b.

Once the rotation of the cap 220 is complete such that the screw threads288 a,b are disengaged, the cap 220 can be removed axially off the mainbody 218 with the projections 286 a and 286 b becoming axiallyseparated. Once the rotation of the catheter 216 is complete, the fins282 travel circumferentially over the end of the ramp formations and nofurther axial movement occurs.

Although the priming mechanism shown in FIG. 15 comprises a plurality ofhelical fins 282, e.g. two, which engage with a corresponding number oframp formations 284 on the storage chamber 228, it will be appreciatedthat the number of the drive surface/driving elements may be varied.Further, the helical surfaces which provide cam-like action may beprovided by any suitable formations and the embodiments of fins and rampformations are only provided as examples. For example, both storagechamber 228 and catheter 216 could be provided with ramp formationsand/or fins, or some combination thereof. Other cam-like arrangementswhich translate rotational movement into linear axial movement may beprovided, such as screw threads similar to those provided for theengagement of the cap 220 and main body 218.

FIGS. 13, 16 a and 16 b show an embodiment of how the storage chamber228 may be constructed in more detail. Thus, there is shown a storagechamber 228 provided by multi-part construction in which a first part231 and a second part 235 are joined together to provide the storagechamber wall. FIG. 13 shows the two-part construction in which the firstdistal part 231 is fitted to a second proximal part 235. The proximalpart 235 comprises a radially extending wall which provides the terminalaxial end wall of the storage chamber compartment in which the majorityof the wetting agent is located. The distal part 231 comprises a distalend wall of the storage chamber compartment and the radially outer wall.

The internal surface of the storage chamber wall comprises a pluralityof radial projections in the form of fins 290. The fins 290 arecircumferentially distributed so as to be angularly separated from oneanother about the longitudinal axis 222. The fins 290 extend axially andradially so as to lie in a plane defined by the longitudinal axis 222 ofthe catheter assembly. The fins 290 may be provided in diametricallyopposed pairs.

As can be seen, the radially inner edges 291 of the fins 290 may beprovided at a common radial distance from the central longitudinal axis222 of the catheter 216 such that, in combination, the radial inneredges 291 of the fins 290 provide a guide tube to keep the catheter 216and storage chamber 228 concentrically aligned. The radius of the guidetube may correspond to or be larger than the proximal sealing surface233 b such that the sealing surface 233 b can pass unhinderedtherethrough whilst maintaining concentricity.

The proximal axial edges 292 of the fins 290 which define the axialextent of the fins 290 may terminate short of the proximal end wall ofthe storage chamber 228 so as to provide edges 292 which define a voidin which the proximal seal element 233 a can be provided. Thus, theproximal axial edges 292 of the fins 290 provide, in combination, a seatagainst which the seal element 233 a can be located during assembly ofthe storage chamber 228 and also during use such that the proximal sealis axially restrained during the transition of the catheter 216 from thestowed position to the wetting position and during the withdrawal of thecatheter 216.

Although FIG. 16 a shows only tour fins 290 in the sectional view, itwill be appreciated that a fewer or greater number of fins 290 may beused. It will also be appreciated that although fins 290 provide aconvenient structure between which the wetting agent can be storedwhilst providing suitable strength and surface area for guiding thecatheter and/or providing a seal seat, other formations may be used. Forexample, the formations may be provided by any combination ofprojections such as ribs, pins, pedestals or flanges for example.

As noted above, the distal end of the storage chamber 228 may beprovided with one or more features which are used as part of a primingmechanism 281. Thus, as can be seen, the distal end of the storagechamber 228 in FIGS. 16 a and 16 b comprises the ramp formations 284which engage with the helical fins 282 provided on the catheter body243.

The ramp formations 282 are provided at the terminal end of an annularflange 293 which extends from the main storage compartment. In theembodiment shown, the ramp formations 282 are provided by triangularcut-outs in the annular flange 282, with the hypotenuse of the triangleproviding the engaging surface. The use of the annular flange 282 allowsthe ramp formations to be located in a close radial proximity to thecatheter 216 which allows the corresponding fins 282 to be smaller. Theannular flange 282 also provides a convenient location for the distalseal 237 which resides between the ramp formations 284 and distal radialwall of the main storage compartment of the storage chamber 228.

The attachment of the first 231 and second 235 parts of the storagechamber 228 can be via any suitable connection such as: an interferencefit, e.g. a push-fit or click-fit; by adhesion; welding; screw thread orclamp, for example. The embodiment of FIGS. 13, 16 a and 16 b is shownas being a click-fit attachment in which the parts 231, 235 are pushedand clicked together such that a circumferential rib is located within acorresponding groove.

The external surface of the proximal part 235 is configured to providean insertion guide 225. Hence, the external surface may be roundedand/or tapered such that it can be utilised to comfortably locate theinsertion guide 225 in the entrance to the urethra.

In more detail, in some embodiments, the insertion guide 225 (which maybe referred to as a gripper) may be an annular member located radiallyoutwardly of the catheter tube 232 or catheter body 243 when stowed. Theradially outer surface of the insertion guide 225 may be configured tobe gripped by a user's fingers and may include one or more surfacefeatures, such as annular grooves (not shown) for improving grip anduser dexterity.

The insertion guide 225 is configured to remain external to the urethrawhen the catheter tube 232 is inserted and so is retractable. Hence, thecatheter tube 232 can pass through the insertion guide 225 such that theinsertion guide 225 moves rearwards to towards the outlet end 226 duringinsertion. When fully retracted, the insertion guide 225 may abut thedistal end of the catheter body 243.

Thus, where the storage chamber comprises an insertion guide 225, thestorage chamber 228 complete with insertion guide 225 may be releasedfrom the external housing when the catheter 216 is withdrawn.

The general procedure relating to the insertion of the catheter 216 andinsertion guide 225 is described previously and not repeated here.

To enable the insertion guide 225 to be correctly placed at theinsertion end 226 of the catheter ready for use (as shown in FIG. 11 ),the storage chamber 228 may be retained within the external housing 212whilst the catheter 216 is removed and the proximal end of the cathetertube 232 is aligned with the insertion guide 225. In order toconveniently withdraw the insertion guide 225 from the housing 212 withthe catheter 216, the catheter arrangement 210 may comprise an optionalretractable sheath 234 located radially outside of the catheter tube232. Alternatively, the insertion guide could simply be pulled out byhand.

FIGS. 11 and 19 show a retractable sheath 234 in a stowed configuration.The sheath 234 extends from an attachment 234 a on the catheter body 243to an attachment 234 b on the distal side of the storage chamber 228.The sheath 234 is flexible and retractable with the insertion guide 225.Hence, when the catheter 216 and insertion guide 225 are located withinthe housing 212, the sheath 234 is provided in a stowed configurationwhich is depicted in FIG. 11 , and when the catheter 216 is withdrawn,the sheath unfurls from the stowed configuration to a deployedconfiguration in which it is fully extended and acts to tether thestorage chamber to the catheter such that a continued withdrawal of thesheath 234 results in the withdrawal of the storage chamber andinsertion guide 225.

It will be appreciated that, in embodiments where an insertion guide 225is not provided, the storage chamber 228 may not comprise the proximalannular flange which forms part of the proximal part 235, and may not beretained within the housing 212 when the catheter 216 is removed. Insuch a case, the sheath 234 may also be omitted.

To enable its removal, the storage chamber 228 may be retained withinthe external housing 212 by a releasable coupling 295, (as best seen inFIG. 18 and described below). The releasable coupling 295 may releasethe storage chamber 228 when a predetermined amount of axial tension,i.e. a withdrawing pulling force on the storage chamber is applied orexceeded. Once the predetermined amount of axial tension has beenapplied or exceeded, the storage chamber may be released by thereleasable coupling and withdrawn from the external housing.

The axial tension may be applied to the storage chamber 228 directly orindirectly. Thus, in some embodiments, a user may grip the storagechamber 228 or a portion thereof and withdraw it, together with thecatheter 216. In some embodiments, the storage chamber 228 and catheter216 may be coupled together such that withdrawing of the catheter 216causes the storage chamber 228 to be withdrawn from the external housing212. In some embodiments, the coupling between the storage chamber andcatheter may be provided by a tether such as the retractable sheath 234.

To prevent the rotation of the storage chamber 228 with the catheter 216during the transition between the sealed configuration and the primedconfiguration, the storage chamber 228 may be rotationally fixed to themain body 218. An embodiment of a coupling 295 configured preventrelative rotation is described in connection with FIGS. 16 b , whichshows the exterior of the storage chamber 228; FIG. 17 , which shows thestorage chamber section 219 without the storage chamber 228 housedtherein; and FIG. 18 which shows the storage chamber 228 and storagechamber section 219 combined. As described below, the coupling 295 maybe configured to be a releasable coupling, such that the coupling 295 isreleased once a predetermined force threshold is exceeded in the axialdirection.

The exterior of the storage chamber 228 may be provided by an externalsurface 294 which, in the described embodiment, is generallycylindrical. The external surface 294 may comprise one or moreanti-rotation and/or axial retention features such as a one or morerecesses. A plurality of circumferential recesses may be provided suchthose provided by the castellated annular groove 296.

The storage chamber section 219 may comprise an elongate tubular memberwhich extends from proximal end to a distal end. The external surface ofthe storage member section 219 may provide a portion of the externalsurface of the external housing 212 and/or one or more features forattaching the cap 220 to the main body 218 such as the aforementionedscrew threads 288 b, and/or one or more features 297 for receiving ahermetic seal 297 a shown in FIG. 11 which may be provided between thecorresponding terminal ends of the cap 220 and main body 218 and whichis irreversibly removed or broken as the cap 220 is removed, as wellknown in the art.

The interior of the storage chamber section 219 comprises a cylindricalcavity 219 a in which the storage chamber 228 is received and mayinclude one or more features of the coupling 295 for engaging thestorage chamber 228 to prevent axial and/or radial movement of thestorage chamber 228 relative to the housing 212.

The coupling 295 part provided by the storage chamber section 219comprises a plurality of circumferentially distributed prongs 298 whichare substantially rotationally rigid to the extent where they act incombination to prevent rotation of the storage chamber when engaged inannular castellated groove 296, and radially compliant such that, whenthe storage chamber 228 and chamber storage section 219 are urgedaxially apart, the prongs 298 flex outwardly thereby releasing thestorage chamber 228. When under the predetermined axial force threshold,the prongs 298 remain engaged with the castellated groove 296 on theexternal surface 295 of the storage chamber wall.

The number of prongs in FIGS. 17 and 18 is eight. However, the numbermay) e greater or fewer than this in some embodiments.

The castellated groove 296 comprises an annular groove which extendsaround the external surface 294 of the storage chamber 228 and ispartitioned so as to provide and a circular array of recesses in whichthe tips of the prongs 298 can be received. It will be appreciated thatin other embodiments, the recesses may be fewer in number and moredispersed than shown.

The prongs 298 comprise projections having a limb 298 a and a tipportion 298 b. The limb 298 a extends axially towards the proximal endof the main body 218 from a radially extending internal surface of thestorage chamber section 219. The limbs 298 a extend from a distal fixedend to a proximal free end. The free end includes the tip portion 298 bwhich extends radially inwards to provide hooks which are received inthe recesses of the storage chamber external surface 294 so as toprovide a clasp. The radially inner surface of the storage chambersection which receives the storage chamber 228 is flush with theinternal surface of the cylindrical housing in which the storage chamberis received.

When viewed along the longitudinal axis in the distal direction, theradially inner edge of the proximal end of the prong tip portions 298 bare tapered such that prongs 298 can more readily receive and be urgedapart by the storage chamber 228 when the storage chamber 228 isinserted into the storage chamber section 219 along the longitudinalaxis.

As noted, the releasably coupling requires an increased axial force toactivate. The increase in force ensures that the catheter tube is fullywithdrawn such that the storage chamber 228/insertion guide 225 is inthe correct location relative to the insertion end and that theretractable sheath is fully extended. It may also provide mechanicalfeedback to the user to indicate that the catheter has been withdrawn toits full extent and can be reinserted if required.

In some embodiments, when the storage chamber 228 is left within thehousing 212 following the withdrawal of the catheter 216, the storagechamber 228 may be attached to or form part of the housing 212 and thecoupling 295 may not be required.

In use, and with reference to the catheter assembly shown in FIG. 2 , auser may rotate the cap 220 to break the hermetic seal 297 a/297 b. Therotation of the cap 220 results in the rotation of the catheter 216 viathe rotational engagement provided by radially projections 286 a and 286b. The rotation of the catheter 216 results in the drive surface anddriving elements provided by cam drive 281 urging the storage chamber228 and catheter 216 axially apart and an axial sliding of the proximalseal element 233 a to provide the catheter assembly in a primedconfiguration. This requires a first step in which a single action froma user, i.e. the rotation of the cap 220 in a first directiontransitions the catheter assembly from a sealed configuration to aprimed configuration.

Following the separation of the seal 233, the catheter 216 may beaxially withdrawn through the storage chamber 228 which functionallyacts as a wetting chamber during the withdrawal. If required, thecatheter may be reinserted into the storage chamber 228 and withdrawnmultiple times to ensure a complete wetting of the catheter tube 232prior to removal.

Where the catheter 216 incorporates an insertion guide 225, theinsertion guide 225 may form part of the storage chamber 228 and may beremoved from the housing 212 with the catheter 216.

It will be appreciated that the above described embodiments in which thecatheter includes a movable insert which is rotated to axially release,either partially or fully, a seal of the storage chamber is advantageousas the mechanical advantage of using a priming mechanism allows the sealto be tighter. Without the mechanical advantage of the primingmechanism, the tighter more effect seal would be difficult to displaceby hand, particularly for weaker or more infirm users.

According to a further embodiment of the present invention there isprovided a catheter assembly 310.

Referring to FIGS. 20 21 a, 21 b, and 21 c, the catheter assembly 310comprises an external housing 312 and a catheter 316. The catheter 316comprises a catheter tube 332 and a sheath 334. The external housing 312and catheter 316 are concentrically arranged such that the catheter 316is located within the external housing 312 in a radially nestedconfiguration.

The catheter assembly 310 may be configured such that the catheter 316may be wetted prior to being withdrawn from the external housing 312.The welling agent used to wet the catheter 316 prior to use and may beheld in a wetting agent storage chamber which is defined between theexternal housing 312 and a first portion of the catheter 316. Thewetting agent may be delivered to the catheter 316 via a wetting chamberwhich is defined between the external housing 312 and a second portionof the catheter 316. The catheter 316 may be movable and may comprise amovable insert.

Again, referring to FIGS. 20 21 a, 21 b, and 21 c, the external housing312 comprises a main body 318 in which a portion of the catheter 316 ishoused and a cap 320, the cap 320 comprising part of the catheter 316,i.e. remaining integral with the catheter even during catheterisationand release of urine from the body.

The external housing 312 provides an enclosed volume in which thecatheter 316 can be housed for storage and transportation prior to use.The main body 318 and cap 320 may provide a sterile cavity in which thecatheter 316 is located. The external housing 312 is generally elongatehaving a longitudinal axis 322 which can be taken to be the principalaxis of the catheter assembly 310. In this embodiment, axial or radialshould be taken to be with reference to the longitudinal axis 322 unlessstated otherwise.

The enclosed volume provided by the external housing 312 is defined byan external wall of the housing 312 which extends from a first proximalend 313, which receives an insertion end 324 of the catheter 316, to asecond distal end 315 in which a catheter outlet end 326 is received. Inthe embodiment shown, the second end 315 is provided by the cap 320,which comprises part of the catheter 316, and the outlet end 326. Thecap 320 may provide an external handling surface with which a user maywithdraw the catheter 316 from the main body 318.

The external profile of the housing 312 can be any required foraesthetic or functional purposes and, in the example shown, is generallycylindrical, tapering towards the first end to aid insertion into astorage receptacle or pocket, for example, and tapering towards thesecond end along the length of the cap 320.

The cap 320 comprises an open-ended generally cylindrical body having acircumferential external wall which extends coaxially along thelongitudinal axis 322, being open at both ends. The cap 320 mates withthe distal end of the main body 318, such that the cap 320 is receivedwithin the open distal end of the main body 318. However, it will beappreciated that the cap 320 could receive an open end of the main body318 in some embodiments.

The external housing 312 may be used to transport the catheter 316 readyfor use and also to dispose of the catheter 316 following use.

With reference to FIGS. 20, 22 a and 22 b, the cap 320 may provide anenclosure which defines a wetting agent storage chamber 321 for awetting agent (not shown). The wetting agent storage chamber 321 isformed between the cap 320 and a moveable insert which, in thisembodiment, is provided by a connector 323 which comprises a part of thecatheter 316, connecting the catheter tube 332 to the catheter outlet326, as will be described in detail below. Thus, the connector 323 maybe provided within the external housing 312 in a spaced relation so asto define a cavity 321 therebetween.

The axial bounds of the wetting agent storage chamber 321 may be definedby a first 327 and a second 329 radially projecting wall projecting infrom an inner wall of the cap 320. The first wall 327 may be arrangedcloser to the insertion end 324 of the catheter 316 than the second wall329, which may be arranged proximate to the second distal end 315 of themain body.

The first 327 and second 329 walls may comprise one or more steps. Asillustrated in FIGS. 22 a and 22 c , the first wall 327 is formed as aseparate component to the remainder of the cap 320, and comprises twosteps, a first step 327 a and a second step 327 b; the second step 327 barranged radially inwards and axially toward the insertion end 324 ofthe first step 327 a. Both steps in the first wall comprise a firstsection projecting radially inwards and a second portion extendingaxially towards the insertion end 324, thus forming two tubularsections, arranged coaxially with the cap 320. The second tubularsection 327 b′ may form a first sealing surface 327 b′ for sealing thewetting agent storage chamber 321 (described in detail below). Thesecond wall 329 may comprise one or more steps. As illustrated in FIGS.22 a,b , the second wall 329 comprises a single step, with a firstportion 329 a projecting radially inwards from the inner wall of the cap320 and the second portion 329 b extending perpendicular to the firstportion 329 a and axially towards to the insertion end 324 so as to forma tubular section arranged co-axially and radially inwards to the cap320. The second portion 329 b of the second wall may form a secondsealing surface 329 b for sealing the wetting agent storage chamber 321(described in detail below). The cavity may be referred to as a wettingagent storage chamber 321 or a reservoir 321.

The wetting agent storage chamber 321 is sealed in a first configuration(as shown in FIG. 22 a ) such that the wetting agent is retainedtherein, and open in a second configuration (as shown in FIG. 22 b )such that the welling agent can flow out of the wetting agent storagechamber 321 and contact the catheter tube 332. When in the openconfiguration, the internal volume of the wetting agent storage chamber321 may be in fluid communication with a wetting chamber 330 in with thecatheter tube 332 is located such that the wetting agent can flow fromthe welling agent storage chamber 321 to the wetting chamber 330 andthus to the catheter tube 332.

With reference to FIGS. 220 , the connector 323 is radially nestedwithin the cap 320, the two components defining the wetting agentstorage chamber 321. The connector 323 may comprise a tubular wall whichis configured to define a portion of the wetting agent storage chamber321 on a radially outer side thereof and a portion of the drainage path(as described in detail below) on a radially inner side thereof.

The connector 323 may comprise an elongate thin-walled structure whichextends longitudinally along the principal axis 322 of the catheterassembly 310. The connector 323 comprises an open first end which isconfigured to receive the catheter tube 332 and a closed second endproximate to the outlet end 326. The second end of the connector maycomprise a drain 331, an end wall 337 and a tab 339 for opening thedrain 331. The end wall 337 may be a radially extending, axially facingdisk with a first face which closes the second end of the connector 323and a second face opposite the first. On the second face of the end wall337 there may be arranged a tab 339 flexibly joined to the end wall 337in the form of a ring pull. Arranged on the connector 323 proximate tothe end wall 337 are one or more apertures which form a drain 331,providing a fluid connection between the interior to the connector 323and the exterior of the catheter assembly 310.

As previously stated, the connector 323 is located radially within thecap 320, to facilitate this the radially outer surface of the connectorproximate to the first open end may be shaped and sized to rest in thesecond tubular section 327 b′ of the cap, forming the corresponding partof the first sealing surface. To improve the wetting agent storagechamber seal, a sealing means, such as a sealing element 370 may beprovided. In the illustrated embodiment the sealing element is providedin the form of an O-ring 370 arranged on the radially outer surface ofthe connector, within a recess 371 to restrict the motion of the O-ring370 relative to the connector 323. It will be appreciated by thoseskilled in the art that the sealing element may also be provided on thefirst wall 327, or on both the connector 323 and the first wall 327.

To ensure that the wetting agent storage chamber 321 remains sealedduring transport and storage, and to ensure that it is not accidentlydeployed into the second configuration, the connector 323 and first wall327 may also comprise a retention mechanism 380. The retention mechanism380 comprises a retention clip 380 a, arranged circumferentially withinand projecting radially inwards of the first sealing surface 327 b′; anda corresponding groove 380 b arranged on the radially outer surface ofthe connector 323, be appreciated that the shape, and optionally,material of the retention mechanism 380 can be selected to ensure theretention mechanism 380 disengages when a predetermined force isapplied.

To further facilitate the arrangement of the cap 320 and connector 323,the connector 323 may be provided with a plurality of projecting ribs345 projecting radially outward about the circumference of the outersurface of the connector. As seen in FIG. 22 a,b there are providedthree ribs 345, a first rib 345 a is arranged approximately half wayalong the axial length of the connector 323, with the second 345 b andthird 345 c ribs arranged between the first 345 and the drain 331. Thefirst rib 345 a extends such that its radial diameter is greater thanthe radial inner diameter of the second sealing surface 329 b. Thesecond 345 b and third 345 c ribs are configured such that they mayslidably move in an axial direction within the second sealing surface.

The combination of a first, larger stop rib 345 a and two smaller guideribs 345 b 345 c provide a number of functions. Firstly, they provide aseal to prevent wetting agent from leaking from the catheter assembly310 during storage and transport. Secondly, the guiding ribs 345 b,cguide the motion of the connector in and between the sealedconfiguration (as shown in FIG. 22 a ) where the third rib 345 c isarranged against the second sealing surface 329 b and the openconfiguration (as shown in FIG. 22 b ) where the second rib 345 b isarranged against the second sealing surface 329 b. The stop rib 345 alimits the extent of the distal axial movement of the connector 323 andcatheter tube 332, such that they cannot be moved beyond the openconfiguration and pulled out of the cap 320.

In use, the user pulls the tab 339, once a predetermined force isapplied, the retention mechanism 380 disengages, such that the connector323 and catheter tube 332 move in a distally axial motion relative tothe cap 320 moving the wetting agent storage chamber 321 from the sealedconfiguration to the open configuration. The O-ring 370 moves axiallyaway from the first sealing surface 327 b′, breaking the seal of thewetting agent storage chamber 321.

As the connector 323 is moved axially through the cap 320 the alignmentis maintained by the second 345 b and third 345 c ribs, with at leastone arranged against the second sealing surface 329 b at all times. Theextent to which the wetting agent storage chamber can be opened beingdefined by the first rib 345 a contacting the second sealing surface 329b.

Once the catheter 316 is in the open configuration, the wetting agent isreleased from the wetting agent storage chamber 321 into the wettingchamber 330, wetting the catheter 316, as described below.

Referring to FIGS. 21 and 22 a-c, the catheter 316 may be any suitablecatheter known in the art. In this embodiment the cap 320 comprises partof the catheter 316, the cap 320 is formed in two parts a top cap 320 awhich defines the radially outer wall of the wetting agent storagechamber and a bottom cap 327 which forms the first wall 327.

As shown, the catheter 316 also comprises a catheter tube 332.

The catheter tube 332 may be may be an elongate thin-walled structurewhich extends longitudinally along the principal axis 322 of thecatheter assembly 310. The catheter tube 332 may be comprised of aflexible material. A first end of the catheter tube 332 may be closedwith a hemi-spherical shape, and form the insertion end 324 of thecatheter 316, the hemispherical shape aiding with insertion.

Proximate to the insertion end 324 there may be provided one or moredrainage apertures 333 which act as inlets for receiving urine from thepatient's bladder. In this embodiment the drainage apertures 333 areoval in shape with the major axis being parallel with the principal axis322. It will be appreciated that the size and shape of the drainageapertures 333 may differ.

The exterior surface of the catheter tube 332 may be, as outlined in theprevious embodiments, functionalised such that when wetted by thewetting agent the co-efficient of friction of the catheter tube 332 isreduced.

The end of the catheter 316 distal to the insertion end 324 is providedwith a catheter outlet end 326. In this embodiment the catheter outletend 326 is provided as part of the connector, in other embodiments theymay be a separate component. The catheter 316 is configured to providefluid communication between the drainage apertures 333 and the drain331.

FIGS. 20 and 21 c and 22 a,b also show an optional sheath 334. Thesheath is formed of a flexible material and is arranged surrounding thecatheter tube 332. The sheath is coupled at a first end to the cap 320on the first wall 327 thereof, and at a second end to an insertion guide325. The insertion guide 325, or part thereof, is comprised of anelastically deformable material.

In use, after completing the wetting cycle as described above, the userwithdraws the wetted catheter 316 from the catheter assembly 310.Holding the gripping surface of the cap 320, and where present, theinsertion guide 325, the user directs the catheter tube 332 into acanal, vessel, passageway, body cavity, etc. for removal of fluidtherefrom.

Where the sheath 334 and insertion guide 325 are present, the user gripsthe insertion guide 325 to guide the catheter tube 332. The usersqueezes the insertion guide 325, deforming it such that it engages withthe catheter tube 332, restricting axial motion of the catheter tube 332through the inserter guide 325 and inserts a first section of thecatheter tube 332 exposed from within the sheath 334 into the canal,vessel, passageway, body cavity etc. Once the first section of thecatheter tube 332 has been inserted, the user relaxes their grip on theinsertion guide 325, allowing it to return to its original shape, andslidably draws the insertion guide 325 along the catheter tube 316 awayfrom the insertion end 324, furling a portion of the sheath 334 andexposing a second section of the catheter tube 316. The process is thenrepeated, with the user squeezing the insertion guide 325 to restrictthe motion of the insertion guide 325 with respect to the catheter tube316 and thereafter the second section of the catheter tube is inserted.The process is repeated until the catheter tube 316 is insertedsufficiently into the canal, vessel, passageway, body cavity etc.

In this embodiment, the catheter 316 is a female urinary catheter 316,with the catheter configured for insertion into a female patient'sbladder via the urethra. Upon insertion into the patient's bladder fluidenters the interior of the catheter tube 16 via the drainage apertures333, flowing through the catheter 316 to and discharged at the drain326.

Once the bladder is drained the catheter 316 can with withdrawn from thebladder and urethra, placed back within the main body 318 for disposalas outlined above.

The one or more embodiments are described above by way of example only.Many variations are possible without departing from the scope ofprotection afforded by the appended claims.

For example, whilst the embodiments are all female intermittent urinarycatheters, with an exemplary length of between 90 mm to 200 mm. e.g.between 130 mm and 155 mm, such as about 135 mm and the catheterassemblies have a length corresponding to the length of the catheter,such as a closed length of the casing of between 2 mm and 10 mm longerthan the length of catheter (e.g. 10-25 cm; between 140 mm and 165 mm,such as 142 mm), it is considered that teachings could be applied tomale urinary intermittent catheters (which are typically longer) or evenother types of catheter. Similarly, although the embodiments havefunctionalised hydrophilic surfaces which become slippery when wettedwith a wetting agent such as water, the wetting agent could be alubricant instead.

1. A catheter assembly comprising: a catheter; and a wetting agentstorage chamber in which the catheter is located, wherein the wettingagent storage chamber comprises at least one projection configured toguide the catheter within the wetting agent storage chamber, wherein theat least one projection retains a seal element in the wetting agentstorage chamber during withdrawal of the catheter.
 2. The catheterassembly of claim 1, wherein the at least one projection comprises aplurality of ribs.
 3. The catheter assembly of claim 2, wherein theplurality of ribs extend axially and radially.
 4. The catheter assemblyof claim 1, wherein the wetting agent storage chamber comprises anaxially extending radially outer wall and at least one radiallyextending end wall.
 5. The catheter assembly of claim 4, wherein theplurality of projections extend from either or both of the radiallyouter wall or the at least one end wall.
 6. The catheter assembly ofclaim 4, wherein the plurality of projections extend radially inwardsfrom the radially outer wall.
 7. The catheter assembly of claim 1,wherein the wetting agent storage chamber comprises at least oneradially extending end wall and the at least one projection extendsaxially within the wetting agent storage chamber, the at least oneprojection terminating short of the end wall to define a void.
 8. Thecatheter assembly of claim 1, wherein the catheter defines alongitudinal axis and each of the plurality of projections lies in aplane defined by the longitudinal axis.
 9. The catheter assembly ofclaim 1, wherein the seal element is an O-ring.
 10. The catheterassembly of claim 1, wherein the seal element is an X-ring.
 11. Thecatheter assembly of claim 1, wherein the seal element is an U-cup seal.12. The catheter assembly of claim 7, wherein the seal element is seatedin the void.
 13. The catheter assembly claim 1, wherein the wettingagent storage chamber comprises two openings arranged at opposing axialends of the storage chamber through which the catheter passes, theprojections defining a channel between the two openings.
 14. Thecatheter assembly claim 1, wherein the inside edges of the projectionsdefine a guide for guiding the passage of the catheter during awithdrawal of the catheter.
 15. The catheter assembly of claim 14,wherein the diameter of the guide is approximately equal to the diameterof one or more openings of the wetting agent storage chamber.
 16. Thecatheter assembly of claim 13, wherein the inside edges of theprojections define a guide for guiding the passage of the catheterduring a withdrawal of the catheter, and wherein the guide extends atleast 80% of the distance between the two openings.
 17. The catheterassembly of claim 14, wherein the separation between the inside edges ofadjacent projections is less than the diameter of the catheter. 18-23.(canceled)
 24. The catheter assembly of claim 1, wherein the assemblyhas a length of between 2 mm and 10 mm longer than the length of thecatheter.
 25. The catheter assembly of claim 1, having a length of 10-25cm.
 26. The catheter assembly of claim 1, having a length of between 140mm and 165 mm.
 27. A catheter assembly, comprising: a catheter; awetting agent storage chamber in which the catheter is located, whereinthe wetting agent storage chamber comprises: at least one projectionconfigured to guide the catheter within the wetting agent storagechamber, wherein the at least one projection extends axially within thewetting agent storage chamber; and at least one radially extending endwall; and a void positioned between the at least one projection and theend wall; and a seal element positioned in the wetting agent storagechamber and seated in the void, wherein the at least one projectionretains the seal element in the wetting agent storage chamber duringwithdrawal of the catheter.